1. No category

Profile
Type
CITY
STATE
Country
Scheme
Scope
A & M Biomedical
Single
Laguna Hills
CA
USA
ISO 13485:2003
Contract manufacture and distribution of non-sterile and sterile, non-active and active medical
devices.
A.J. Precision, Inc.
Single
Agawam
MA
USA
ISO 9001:2008
The Manufacturing and Assembly of Precision Machined Components.
A.L.I. Label Systems
Single
Galt
CA
USA
ISO 9001:2008
Design, Manufacture and Sales of Tags and Labels.
AADCO Medical Inc.
Secondary
Randolph
VT
USA
EN ISO 13485:2012
IS EN ISO 13485 Scope: The Design, Manufacture and Distribution of Non-Sterlie Gel Pads
and Positioners for Patient Positioning during Medical ExaminationISO 9001:2008 Scope: The
Design, Manufacture and Distribution of Ergonomic X-Ray Protective and MRI Safe Medical
Equipment and Devices
AADCO Medical Inc.
Primary
Randolph
VT
USA
EN ISO 13485:2012
IS EN ISO 13485 Scope: The Design, Manufacture and Distribution of Gel Pads and Patient
Positioners, Conventional and MRI Safe Examination Lamps and Ceiling Suspension
Systems for Medical ExaminationISO 9001:2008 Scope: The Design, Manufacture and
Distribution of Ergonomic X-Ray Protective and MRI Safe Medical Equipment and Devices
Single
Dublin 14
Ireland
ISO 9001:2008
AAREN Scientific France
Secondary
Paris
France
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
AAREN Scientific, Inc.
Secondary
Ontario
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
AAREN Scientific, Inc.
Primary
Ontario
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Single
Co Sligo
Ireland
EN ISO 13485:2012
The design, manufacture, sterilization and distribution of adult and paediatric enteral Feeding
kits, including tubes, connectors and feeding bags, and the servicing of enteral feeding
pumps.
ACM Machining, Inc.
Primary
Rancho Cordova
CA
USA
ISO 9001:2008
Contract machine shop for the manufacture of metal components for the oil and gas industry,
automotive filtration and general machining.
ACM Machining, Inc.
Secondary
Rancho Cordova
CA
USA
ISO 9001:2008
Contract machine shop for the manufacture of metal components for the oil and gas industry,
automotive filtration and general machining.
COMPANY
Aalto Bio Reagents Ltd
Abbott Ireland
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The supply of biological raw materials to the in-vitro diagnostics industry
4/10/2015
COMPANY
Actiontec Electronics, Inc.
Actiontec Electronics, Inc.
Actiontec Electronics, Inc.
Profile
Type
Secondary
Primary
CITY
Colorado Springs
Sunnyvale
STATE
CO
CA
Scheme
Scope
TL 9000 R5.0/5.0
TL9000-HSV Scope: Design, Distribution, Support and Servicing of Broadband Products for
Telecommunications Service Providers for the following service categories: 6.2.3.2 Wireless
Modems, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope:
Design, Distribution, Support and Servicing of Broadband Products for Telecommunications
Service Providers.
TL 9000 R5.0/5.0
TL9000-HSV Scope: Design, Distribution, Support and Servicing of Broadband Products for
Telecommunications Service Providers for the following service categories: 6.2.3.2 Wireless
Modems, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope:
Design, Distribution, Support and Servicing of Broadband Products for Telecommunications
Service Providers.
USA
TL 9000 R5.0/5.0
TL9000-HSV Scope: Design, Distribution, Support and Servicing of Broadband Products for
Telecommunications Service Providers for the following service categories: 6.2.3.2 Wireless
Modems, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope:
Design, Distribution, Support and Servicing of Broadband Products for Telecommunications
Service Providers.
USA
USA
Secondary
Fremont
Acumuladores Industriales EnerSys, S.A.
Primary
Vizcaya
Spain
ISO 9001:2008
Sales and installation of reserve power industrial batteries. Sales, assembly and aftersales of
motive power industrial batteries and chargers.
Acumuladores Industriales EnerSys, S.A.
Secondary
Barcelona
Spain
ISO 9001:2008
Sales and installation of reserve power industrial batteries. Sales, assembly and aftersales of
motive power industrial batteries and chargers.
Acumuladores Industriales EnerSys, S.A.
Secondary
Madrid
Spain
ISO 9001:2008
Sales and installation of reserve power industrial batteries. Sales, assembly and aftersales of
motive power industrial batteries and chargers.
Acumuladores Industriales EnerSys, S.A.
Secondary
Valencia
Spain
ISO 9001:2008
Sales and installation of reserve power industrial batteries. Sales, assembly and aftersales of
motive power industrial batteries and chargers.
Adhesive Packaging Specialties, LLC
Single
Peabody
USA
AS 9100 - C
The Custom Packaging of Single and Multi-Component Adhesive Systems for Aerospace and
Industrial Applications.
Adhesives Research Ireland Ltd
Single
Raheen, Limerick
Ireland
EN ISO 13485:2012
Adhesives Research Ireland Ltd.,
Primary
Raheen, Limerick
Ireland
ISO 9001:2008
Research, development, manufacture and sale of speciality adhesives and adhesives coated
products for medical, pharmaceutical, automotive, aerospace and general manufacturing
industries
Secondary
Munich
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
ADTRAN GmbH
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
Country
MA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design and development, and manufacture of adhesives, adhesive-coated films,
laminates and other specialty films for use in the medical devices industry.
4/10/2015
Profile
Type
CITY
ADTRAN GmbH
Secondary
ADTRAN GmbH
COMPANY
Country
Scheme
Bruchsal
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
Secondary
Greifswald
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
ADTRAN GmbH
Secondary
Munich
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
ADTRAN GmbH
Secondary
Bruchsal
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
ADTRAN GmbH
Secondary
Greifswald
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
ADTRAN GmbH Facility
Secondary
Berlin
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
ADTRAN GmbH Facility
Secondary
Berlin
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access
related telecommunication products and solutions.
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment
and associated software.TL9000- H,S scope: TL 9000-HS R5.0/R5.0 for the following
hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1
Enclosures, 3.2.2.1.1 Metallic Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems,
3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL,
3.2.4.3 Asymmetric DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical
Operations Support Systems, 6.2.4 Digital Data Service Units, 6.2.5 Passive Optical Network
Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment
and associated software.TL 9000-HS R5.0/R5.0 for the following hardware and software
product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1
Metallic Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave,
3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL, 3.2.4.3 Asymmetric DSL,
3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems,
6.2.4 Digital Data Service Units, 6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE
Router, 6.4 Private Branch Exchange (PBX).
ADTRAN Inc.
ADTRAN India Pvt Ltd
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Secondary
Burlington
Hyderabad
STATE
MA
USA
India
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
COMPANY
ADTRAN Networks Pty Ltd.
ADTRAN Optical Systems Group
ADTRAN, Inc.
ADTRAN, Inc.
Profile
Type
Secondary
CITY
Melbourne
STATE
Victoria
Country
Australia
Scheme
TL 9000 R5.0/5.0
Scope
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment
and associated software.TL 9000-HS R5.0/R5.0 for the following hardware and software
product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1
Metallic Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave,
3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL, 3.2.4.3 Asymmetric DSL,
3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems,
6.2.4 Digital Data Service Units, 6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE
Router, 6.4 Private Branch Exchange (PBX).
Secondary
Phoenix
AZ
USA
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment
and associated software.TL 9000-HS R5.0/R5.0 for the following hardware and software
product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1
Metallic Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave,
3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL, 3.2.4.3 Asymmetric DSL,
3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems,
6.2.4 Digital Data Service Units, 6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE
Router, 6.4 Private Branch Exchange (PBX).
Primary
Huntsville
AL
USA
ISO 14001:2004
The design and manufacture of digital telecommunication equipment and associated software
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment
and associated software.TL 9000-HS R5.0/R5.0 for the following hardware and software
product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1
Metallic Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave,
3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL, 3.2.4.3 Asymmetric DSL,
3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems,
6.2.4 Digital Data Service Units, 6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE
Router, 6.4 Private Branch Exchange (PBX).
Primary
Huntsville
AL
USA
TL 9000 R5.0/5.0
Advance Medical Designs
Secondary
Marietta
GA
USA
ISO 13485/CMDCAS
The design and development, manufacture and distribution of sterile and non-sterile
disposable patient drapes, equipment covers, medical waste bags, high pressure lines,
pressure monitoring lines, decanters and related devicesfor infection control and fluid
management.
Advance Medical Designs
Secondary
Marietta
GA
USA
ISO 13485/CMDCAS
The design and development, manufacture and distribution of sterile and non-sterile
disposable patient drapes, equipment covers, medical waste bags, high pressure lines,
pressure monitoring lines, decanters and related devicesfor infection control and fluid
management.
Advance Medical Designs
Primary
Marietta
GA
USA
ISO 13485/CMDCAS
The design and development, manufacture and distribution of sterile and non-sterile
disposable patient drapes, equipment covers, medical waste bags, high pressure lines,
pressure monitoring lines, decanters and related devicesfor infection control and fluid
management.
Advanced Programs, Inc.
Single
Salem
NH
USA
ISO 9001:2008
The design, production and integration of high assurance solutions and hardware to the
United States Government.
AdvanDx
Single
Woburn
MA
USA
I.S.EN ISO13485:2012
Advant Medical Ltd
Single
Co. Galway
Ireland
EN ISO 13485:2012
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design, manufacture and distribution of In-Vitro Diagnostic devices used for rapid
detection and identification of bacteria and yeast in blood cultures.
The contract assembly, manufacture and packaging of non-sterile medical devices including
guidewire and catheter dispensers.
4/10/2015
Profile
Type
CITY
AeroGen Ltd
Single
Co. Galway
Airmar Technology Corporation
Single
Milford
AirXpanders, Inc.
Single
AIXTRON
AIXTRON, Inc.
COMPANY
STATE
Country
Scheme
Scope
Ireland
ISO 13485/CMDCAS
CMDCAS & MD: The design, development and manufacture of Medical Devices and Systems
for Systemic Diagnosis, treatment and drug delivery.
NH
USA
ISO 9001:2008
The Design, Manufacture and Service of Ultrasonic Transducers and Transceivers, Sensing
Instrumentation and Signal Processing Electronics.
Palo Alto
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of active implantable tissue expansion systems for
breast reconstruction applications
Single
Sunnyvale
CA
USA
ISO 9001:2008
The design, manufacture and service of Thin Film capital equipment for advanced
semiconductor manufacturing.
Single
Sunnyvale
CA
USA
ISO 14001:2004
The design, manufacture, service and marketing of thin film capital equipment for advanced
semiconductor manufacturing.
ISO 9k scope:Design, Manufacture, and Distribution of Osmometry Calibration Standards for
the Medical Device Industry, and Sanitization Products for the Agricultural Industry.ISO 13485
scope: Design, Manufacture and Distribution of Disinfecting & Cleaning Agents, and
Disinfectant Indicator Solutions for the Medical Device Industry.
Alden Medical, LLC
Single
West Springfield
MA
USA
ISO 13485:2003
Alfa Scientific Designs, Inc.
Single
Poway
CA
USA
ISO 13485/CMDCAS
Allard Support UK Limited
Single
Co Louth
Ireland
ISO 9001:2008
Allen Medical Systems
Single
Acton
MA
USA
EN ISO 13485:2012
Alliance Technical Solutions, LLC
Single
Salem
NH
USA
AS 9100 - C
Design and Manufacture of High Reliability Power Conversion Products.
Alloy Metal Products
Single
Livermore
CA
USA
AS 9100 - C
The Manufacture and Assembly of Complex Precision Components for the Aircraft, Military,
Medical, Aerospace and Laser Industries.
Primary
San Jose
CA
USA
ISO 9001:2008
Altera Corporation
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design, manufacture, and distribution of in-vitro diagnostic medical devices used to
screen for the presence of drugs of abuse, cancer markers, cardiac markers and
transmissible agents; and for fertility testing and pregnancy testing.
The manufacture and distribution of orthotic devices
The Design, Manufacture and Distribution of Specialty Operating Tables and Positioning
Accessories for the Operating Room.
Design, Development and Provision of Total Solutions, Including Semiconductor Components,
IP, and Development Tools.
4/10/2015
Profile
Type
CITY
Altera Corporation (M) Sdn. Bhd.
Secondary
Bayan Lepas/Penang
American Bio Medica Corporation
Primary
Kinderhook
American Bio Medica Corporation
Secondary
American Durafilm
American Durafilm
COMPANY
Country
Scheme
Scope
Malaysia
ISO 9001:2008
Design, Development and Provision of Total Solutions, Including Semiconductor Components,
IP, and Development Tools.
NY
USA
ISO 13485/CMDCAS
The design/development, manufacture and distribution of in-vitro diagnostic test kits and
related equipment utilizing lateral flow immunoassay technology used in the rapid screening
test of drugs of abuse, infectious diseases and other analytes.
Logan Township
NJ
USA
ISO 13485/CMDCAS
The design/development, manufacture and distribution of in-vitro diagnostic test kits and
related equipment utilizing lateral flow immunoassay technology used in the rapid screening
test of drugs of abuse, infectious diseases and other analytes.
Primary
Holliston
MA
USA
ISO 9001:2008
Manufacture of seamless polyimide tubing and assemblies for the Medical, Aerospace, and
Electronics Industries
Secondary
Cornelius
NC
USA
ISO 9001:2008
Manufacture of seamless polyimide tubing and assemblies for the Medical, Aerospace, and
Electronics Industries
American Tools, Inc.
Single
Bayamon
PR
Puerto Rico
ISO 9001:2008
Fabrication of Sheet Metal Products
AMETEK
Single
Pittsburgh
PA
USA
ISO 9001:2008
The design, manufacture and service of gas and liquid process instruments and instrument
systems for industrial and laboratory applications.
Ametek Power and Data Systems
Secondary
Harleysville
PA
USA
AS 9100 - C
The design and manufacture of aerospace instrumentation to specifications agreed upon with
other Ametek organizations and our customers
Ametek Power and Data Systems
Primary
Binghamton
NY
USA
AS 9100 - C
The design and manufacture of aerospace instrumentation to specifications agreed upon with
other Ametek organizations and our customers.
Ametek Process Instruments
Single
Newark
DE
USA
ISO 9001:2008
The design, manufacture and service of gas and liquid process instruments and instrument
systems for industrial and laboratory applications.
Amnisure International LLC.
Single
Boston
MA
USA
ISO 13485/CMDCAS
The design, manufacture, and distribution of In Vitro Diagnosis Testing for Rupture of Fetal
Membrane and Time to Delivery.
Secondary
Jiangsu
China
ISO 9001:2008
Amphenol (Changzhou) Advanced Connector
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design and manufacturing of backplane systems and high speed, high density connector
components, cables, thermocouple components and assemblies
4/10/2015
Profile
Type
CITY
Amphenol (Changzhou) Advanced Connector
Secondary
Amphenol (Changzhou) Connector System
COMPANY
Country
Scheme
Jiangsu
China
ISO 14001:2004
The manufacture of backplane, connector, cables, thermocouple components and
electromechanical systems.
Secondary
Jiangsu
China
ISO 9001:2008
The design and manufacture of backplanes.
Single
Nashua
USA
AS 9100 - C
Amphenol de Mexico S.A. de C.V.
Secondary
El Dorado
Mexico
ISO 9001:2008
The manufacturing of backplane systems and high speed, high density connector components
and assemblies.
Amphenol InterCon Systems
Secondary
Harrisburg
PA
USA
ISO 9001:2008
Design and manufacturing of interconnection devices and High Speed Cables.
Amphenol Printed Circuit Board Technolog
Single
Nogales, Sonora
Mexico
Mexico
AS 9100 - C
Manufacture of high technology backplanes, daughter cards, flex and rigid flex printed circuits
and value added assembly services for aerospace, military and commercial applications.
Amphenol Printed Circuits
Single
Nashua
NH
USA
AS 9100 - C
Design and manufacture of high technology backplanes, daughter cards, flex, and rigid flex
printed circuits and value added assembly services for aerospace, military and commercial
applications.
Amphenol TCS
Secondary
Winston-Salem
NC
USA
ISO 14001:2004
The manufacture of connector components, metal stampings, conventional and reel-to-reel
insert molded products for the communications, electronic and automotive industries.
Amphenol TCS
Secondary
Nashua
NH
USA
ISO 14001:2004
The manufacture of backplane and connector systems.
Amphenol TCS
Secondary
Winston Salem
NC
USA
ISO 9001:2008
The manufacturing of backplane systems and high speed, high density connector components
and assemblies.
Amphenol TCS
Primary
Nashua
NH
USA
ISO 14001:2004
The design and manufacturing of backplane systems and high speed, high density connector
components and assemblies
Amphenol TCS - CMG
Primary
Nashua
NH
USA
ISO 9001:2008
The design and manufacturing of backplane systems and high speed, high density
connectors, components and assemblies.
Amphenol Backplane Systems
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
NH
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The manufacture of electrical connectors, backplanes and high performance electrical
interconnect systems
4/10/2015
Profile
Type
CITY
Amphenol TCS (Malaysia) Sdn. Bhd.
Secondary
Amphenol TCS (Malaysia) Sdn. Bhd.
Amphenol TCS de Mexico S.A. de C.V.
COMPANY
Country
Scheme
Scope
Penang
Malaysia
ISO 9001:2008
The design and manufacturing of backplane systems and high speed, high density connector
components and assemblies.
Secondary
S.P.T Penang
Malaysia
ISO 14001:2004
The design and manufacturing of backplane systems and high speed, high density connector
components and assemblies
Secondary
El Dorado
Mexico
ISO 14001:2004
The design and manufacture of backplane systems and high speed, high density connector
components and assemblies.
Amulet Technologies, LLC
Single
Campbell
CA
USA
ISO 9001:2008
The design of high performance embedded Graphical User Interface (GUI) solutions for
microcontroller based products.
Amulet Technologies, LLC
Single
Campbell
CA
USA
ISO 14001:2004
The design of high performance embedded Graphical User Interface (GUI) solutions for
microcontroller based products.
Andromeda Systems Incorporated
Single
Orange Park
FL
USA
ISO 9001:2008
Design and Service Provider of Engineering, Maintenance and Logistics, Information
Technology, Program Management, Acquisition Support and Financial Services to include any
other Associated Services to Commercial and Government Enterprises.
AOTI Ltd
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
Applied Ceramics, Inc
Single
Fremont
CA
USA
ISO 9001:2008
Applied Circuit Technology Inc.
Single
Richardson
TX
USA
EN ISO 13485:2012
ISO 13485 Scope: The Layout, Manufacture and Final Test of Printed Circuit Boards and
Electromechanical Assemblies used for Medical Devices.9K Scope: The Layout, Manufacture
and Final Test of Printed Circuit Boards and Electromechanical Assemblies.
Applied Science, Inc
Single
Grass Valley
CA
USA
EN ISO 13485:2012
The Manufacture and Distribution of Electronic Blood Collection and Mixing Systems.
APS Materials Inc
Single
Co. Waterford
Ireland
EN ISO 13485:2012
The manufacture and application of Thermal Spray Coating Solutions for the Bio-Medical and
other industries.ISO 9k:The manufacture and application of Thermal Spray Coating Solutions
for the Bio-Medical and other industries
AQF Limited
Single
Co. Meath
Ireland
EN ISO 13485:2012
MD Scope: The manufacture and distribution of foam components and products for the
medical device industry.ISO9K Scope: The manufacture of flexible foam products and
packaging material.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The Manufacture and Distribution of Oxygen Therapy Systems.
The manufacture and service of ceramic precision components for the high tech industries.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
ARC Technology Solutions, LLC
Single
Nashua
NH
USA
ISO 9001:2008
Arcadyan Technology Corp.
Single
Hsinchu
Taiwan, R.O.C.
TL 9000 R5.0/5.0
Associates of Cape Cod, Inc.
Single
East Falmouth
USA
ISO 13485/CMDCAS
COMPANY
MA
Scope
Provision of electrical, software and test engineering and manufacturing services for the
electronic industry.
ISO 9001:2008 Scope - Design and Distribution of Wireless Telecommunication
Products.TL9000-H Scope: Design and Distribution of Wireless Telecommunication Products
for the Following Product Category: 6.2.4 Digital Data Service Units.
The Design, Manufacture and Distribution of Limulus Amebocyte Lysate (LAL) Reagents
(including In-Vitro Diagnostic Medical Devices for the Analysis of (1-->3)-ß-D-Glucan to
Support the Diagnosis of Invasive Fungal Disease) andRelated Materials and Equipment;
Contract Testing for Endotoxin and Glucan.
Atotech Taiwan Limited, Advanced Tech Ct
Single
Taoyuan County
Taiwan, R.O.C.
ECCB HSPM
This IECQ HSPM Independent Testing Laboratory (ITL) certificate of approval is applicable to
all electronic components and related materials and processes for the Chemicals analysis for
electronics, general metal finishing and semiconductorindustries.The IECQ HSPM
assessment is conducted in accordance with related IECQ QC 080000 Specification and the
IECQ Rules of Procedure IECQ 03-5.
Atotech Taiwan Ltd, Materials Science La
Single
Taoyuan County
Taiwan, R.O.C.
IECQ ITL
Micro resistance reliability test, mechanical and materials test for electronics, general metal
finishing and semiconductor industries, including test for Measurement of Coating Thickness
by X-Ray FluorescenceSpectrometry (ASTM B568), Peel Strength Test of Copper Film (IPC
TM-650 2.4.8 C), and Interconnect Stress Test (IST, IPC TM 650 2.6.26).
IECQ ITL
Micro resistance reliability test, mechanical and materials test for electronics, general metal
finishing and semiconductor industries, including test for Measurement of Coating Thickness
by X-Ray Spectrometry (ISO3497), Coefficiency of friction testing (PSA C100054), Test for
Simultaneous Thickness and Electrode Potential Determination of Individual Layers in
Multilayer Nickel Deposit (STEP Test, ASTM B 764), Standard Practice forOperating Salt
Spray (Fog) Apparatus (NSS Test, ASTM B117), Test for Copper-Accelerated Acetic Acid-Salt
Spray (Fog) Testing (CASS Test, ASTM B368), and Kesternish test (ASTM D1193).
Taiwan, R.O.C.
IECQ ITL
This IECQ HSPM Independent Testing Laboratory (ITL) certificate of approval is applicable to
all electronic components and related materials and processes for the Chemicals analysis for
electronics, general metal finishing and semiconductorindustries.The IECQ HSPM
assessment is conducted in accordance with related IECQ QC 080000 Specification and the
IECQ Rules of Procedure IECQ 03-5.
Atotech Taiwan Ltd., Advanced Tech Cente
Secondary
Kaohsiung City
Taiwan, R.O.C.
Atotech Taiwan Ltd., Advanced Technology
Secondary
Kaohsiung City
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding
to customer requests, billing customers, processing customer payments, and managing
customer accounts.
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding
to customer requests, billing customers, processing customer payments, and managing
customer accounts.
Austin Energy
Primary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding
to customer requests, billing customers, processing customer payments, and managing
customer accounts.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding
to customer requests, billing customers, processing customer payments, and managing
customer
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding
to customer requests, billing customers, processing customer payments, and managing
customer accounts.
Austin Energy Electric Service Delivery
Secondary
Austin
TX
USA
ISO 9001:2008
System Maintenence & Restoration
Austin Energy Electric Service Delivery
Secondary
Austin
TX
USA
ISO 9001:2008
Calibration; Transformer Sets
Austin Energy Electric Service Delivery
Primary
Austin
TX
USA
ISO 9001:2008
Delivering electric power to Austin Energy's customers by planning, designing, constructing,
operating, and maintaining its electric service delivery infrastructure, operating systems, and
equipment.
Austin Energy Electric Service Delivery
Secondary
Austin
TX
USA
ISO 9001:2008
Distribution, Transmission, and Substation Services; Project Management; Complex Metering
Austin Energy Electric Service Delivery
Secondary
Austin
TX
USA
ISO 9001:2008
Distribution, Network and Illumination Services: Project Management; HVAC
Austin Energy Power Supply
Secondary
Austin
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers,
ERCOT and wholesale markets.
Austin Energy Power Supply
Secondary
Del Valle
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers,
ERCOT and wholesale markets.
Austin Energy Power Supply
Primary
Austin
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers,
ERCOT and wholesale markets.
Austin Energy Power Supply
Secondary
Austin
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers,
ERCOT and wholesale markets.
Single
Richardson
TX
USA
AS 9100 - C
The Layout and Procurement of Printed Circuit Boards, Manufacture and Final Test of Printed
Circuit Board Assemblies, and Electromechanical Assemblies for Medical, Aerospace and
Commercial Devices.
COMPANY
Automated Circuit Design
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Avcor Health Care Products, Inc.
Single
Grand Prairie
TX
USA
EN ISO 13485:2012
The Manufacture, Contract Manufacture, and Distribution of Sterile and Non-Sterile NonInvasive Compression Bandages.
Avenue Mould Solutions Ltd
Single
Co. Sligo
Ireland
EN ISO 13485:2012
The contract manufacture of injection moulded medical device components and the provision
of validation services.
Avocent Corp.
Primary
Huntsville
AL
USA
ISO 9001:2008
The Design, Development, Manufacture, Marketing, Sale and Support of Electronic Devices
for Computer Interface Products.
Avocent Corp.
Secondary
Sunrise
FL
USA
ISO 9001:2008
Engineering software and customer support.
Avocent Corp.
Secondary
Shannon Free Zone,
Shannon Co.
Ireland
ISO 9001:2008
The Design, Development, Manufacture, Marketing, Sale and Support of Electronic devices
for Computer Interface Products.
(ISO 13485 Scope)The manufacturing and distribution of medical devices for use in
orthodontics. Contract manufacturing of non-active metal and plastic components and
subassemblies for use in medical devices.(ISO 9001 Scope) The contract manufacturing of
metal and plastic components and sub-assemblies for use in the medical device industry.
COMPANY
Scope
Azure MicroDynamics, Inc.
Single
Lake Forest
CA
USA
EN ISO 13485:2012
B&G Precision Inc.
Single
Fremont
CA
USA
AS 9100 - C
Contract machining, manufacturing and assembly of components and sub-assemblies for the
aviation, space and defense industries.
B&G Precision Inc.
Single
Fremont
CA
USA
EN ISO 13485:2012
MD Scope: Contract Machining, Manufacture, and Assembly of Medical Device Components
and Non-Active Sub-Assemblies.ISO9K Scope: The Manufacture of Critical Components and
Assemblies for the Medical and Aerospace Industries.
B. Braun Hospicare Limited
Single
County Sligo
Ireland
EN ISO 13485:2012
The design and manufacture of wound care products.
B. Braun Medical Ltd.
Single
Dublin 12
Ireland
ISO 9001:2008
B. L. Industria Otica Ltda.
Single
Brazil
Brazil
EN ISO 13485:2012
B3CG Interconnect
Single
St. Eustache - Quebec
Canada
ECCB HSPM
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The Sales, Marketing, Distribution and after-sales support of pharmaceutical products,
medical devices and equipment.
The manufacture and distribution of contact lenses.
Manufacturing of HSF cables, wire harnesses and electromechanical assemblies for
industrial, medical and communications applications.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Secondary
Fort Wayne
IN
USA
ECCB ECMP (TS-62239)
Designs, Manufactures, Services and Tests Various Products for Avionics, Aerospace,
Space, Internal Systems, Military Products & Systems, and Power Systems.
Primary
Endicott
NY
USA
ECCB ECMP (TS-62239)
Designs, Manufactures, Services and Tests Various Products for Avionics, Aerospace,
Space, Internal Systems, Military Products & Systems, and Power Systems.
Barksdale, Inc.
Single
Los Angeles
CA
USA
ISO 9001:2008
Bausch & Lomb - Iom Spa
Single
Monza Brianza
Italy
EN ISO 13485:2012
MD and ISO9K Scope: The manufacture and distribution of contact lens solutions.
COMPANY
BAE Systems
BAE Systems Controls
Scope
The design and manufacture of hydraulic valves, temperature switches, pressure switches,
transducers, level switches, monitors, magnetic sensors, speed switches and transmitters.
Bausch & Lomb Hastings
Secondary
Hastings
East Susse
United Kingdom
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons,
and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with
EN ISO 11137-1:2006.
Bausch & Lomb Incorporated
Secondary
Rancho Cucamonga
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Secondary
Irvine
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Secondary
Rancho Cucamonga
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Secondary
Rancho Cucamonga
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Primary
Rochester
NY
USA
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular, gaspermeable and soft lens
materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in
accordance with EN ISO 11137-1:2006.
Bausch & Lomb Incorporated
Primary
Rochester
NY
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Profile
Type
Secondary
Secondary
Secondary
Secondary
Bausch & Lomb Ireland
Secondary
Bausch + Lomb OPS BV
Single
CITY
Greenville
Greenville
Wilmington
Clearwater
STATE
SC
SC
MA
FL
Waterford
Country
Scheme
Scope
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons,
and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with
EN ISO 11137-1:2006.
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons,
and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with
EN ISO 11137-1:2006.
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons,
and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with
EN ISO 11137-1:2006.
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons,
and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with
EN ISO 11137-1:2006.
Ireland
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses,
Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting,
and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons,
and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with
EN ISO 11137-1:2006.
Netherlands
EN ISO 13485:2012
The logistics and distribution of contact lenses, contact lens care products, and surgical
products. The management of postponement and repackaging activities for contact lenses
and lens care products.
Costa Rica
ISO 13485/CMDCAS
The design, manufacture, and distribution of sterile intrafallopian tube implants and delivery
systems
The design, manufacture, and distribution of sterile intrafallopian tube implants and delivery
systems.
USA
USA
USA
USA
Bayer HealthCare, LLC
Secondary
Heredia
Bayer HealthCare, LLC
Primary
Milpitas
CA
USA
ISO 13485/CMDCAS
Single
Springfield
MA
USA
ISO 9001:2008
Baystate Metal Solutions Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Design and Manufacture of Precision Sheet Metal and Assembly of Products.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Juncos
PR
Puerto Rico
EN ISO 13485:2012
Primary
Research Triangle Park
NC
USA
IECQ ITL
BD Medical
Single
Franklin
WI
USA
EN ISO 13485:2012
The manufacture, packaging and distribution of pre-filled sterile flush syringes
BD Medical - Diabetes Care
Single
Holdrege
NE
USA
EN ISO 13485:2012
The manufacture, packaging, sterilisation and contract sterilisation of drug delivery devices
including syringes and pen needles, device components for assembly at other BD locations,
and alcohol swabs.
COMPANY
BD Caribe Ltd.
BD Corporate Preclinical Development
Scope
MD & ISO9K Scope: The manufacture of sterile and non-sterile, single use devices including
specialty needles (epidural, spinal, biopsy), safety needle, chest drain valve, bladder drain
catheter, catheter adapter and accessories,micro-collection, specimen collection, blood
transfer and lancets.
This IECQ ITL certification is applicable to all electronic components and related materials
and processes for the: Biocompatibility, saftey and Toxicalogical testing for a wide array of
medical supplies, devices, laboratory equipment and diagnosticproducts.
BD Medical Surgical
Single
Columbus
NE
USA
EN ISO 13485:2012
ISO13485 & 9001:2008: The manufacture of sterile and non-sterile hypodermic needles,
syringes, and components. The manufacture of saline and heparin pre-filled syringes for
irrigation. Irradiation Sterilization in Accordance with EN ISO 11137:2006 .Moist heat
sterilization in accordance with EN ISO 17665-1:2006.
BD Medical, Pharmaceutical Systems
Single
Columbus
NE
USA
EN ISO 13485:2012
The Manufacture of Pre-fillable, Drug Delivery Components. In-house Ethylene Oxide
Sterilization in Accordance with ISO 11135:2007.
BE Peterson Inc.
Single
Avon
MA
USA
ISO 9001:2008
Design and Manufacture of Heavy-Gauge Metal Parts, Equipment and ASME Code Tanks &
Filtration Vessels for Power and Utilities, Medical, Chemical/Environmental/Filtration, and
Other Industrial Applications
Beckman Coulter
Secondary
Fort Collins
CO
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Installation, Service and Customer
Support of Particle Characterization Systems, and the Design, Development, Manufacture
and Service of Cytometry Systems for Research Use Only.
Beckman Coulter (Ireland) Inc.
Secondary
Co Galway
Ireland
ISO 13485:2003
13485 Scope: The design and development, manufacture, distribution and customer support
of clinical chemistry, haematology, heterogenous immunoassay and flow cytometry in vitro
diagnostic devices.9001 Scope: The manufacture and repair of centrifuge rotors.
Beckman Coulter AB
Secondary
SE-168 66 Bromma
Sweden
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes
Beckman Coulter Biomedical GmbH
Primary
Muenchen
Germany
ISO 13485:2003
Design/Development, Manufacture, Supply and Customer Support of Laboratory Automation
Systems
Beckman Coulter Biomedical GmbH
Secondary
Muenchen
Germany
I.S.EN ISO13485:2012
Design/Development, Manufacture, Supply and Customer Support of Laboratory Automation
Systems
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Profile
Type
CITY
Secondary
Country
Scheme
Istanbul
Turkey
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Single
Mississauga, Ontario
Canada
ISO 9001:2008
The sale, installation and service of products for biomedical testing
Beckman Coulter Danmark
Secondary
Vantaa
Sweden
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes
Beckman Coulter Diagnostics Ltd
Secondary
Co. Clare
Ireland
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
Beckman Coulter Eurocenter S.A.
Primary
Nyon 1
Switzerland
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
Beckman Coulter Finland Oy
Secondary
Vantaa
Finland
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes
Beckman Coulter Genomics
Single
Danvers
USA
ISO 9001:2008
Genomic services and the production, contract manufacture and distribution of nucleic acid
purification products.
Primary
Takeley, Essex
United Kingdom
ISO 9001:2008
The provision of genomic services
Beckman Coulter Gmbh
Single
47807 Krefeld
Germany
ISO 13485/CMDCAS
Beckman Coulter GmbH
Secondary
1210 Vienna
Austria
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes
Beckman Coulter GmbH
Secondary
47807 Krefeld
Germany
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Beckman Coulter Biyomedikal Urunler San
Beckman Coulter Canada LP
Beckman Coulter Genomics, Inc.
Beckman Coulter GmbH
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Krefeld
STATE
MA
Germany
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The production and distribution of hematology and immunology consumables.
4/10/2015
COMPANY
Beckman Coulter India Private Limited
Profile
Type
CITY
Secondary Andheri (East), Mumbai
STATE
Country
Scheme
Scope
India
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Beckman Coulter International S.A.
Primary
Nyon 1
Switzerland
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Beckman Coulter International SA
Secondary
10000 Zagreb
Croatia
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Beckman Coulter International SA
Secondary
Czech Republic
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Beckman Coulter International SA
Secondary
02-676 Warsaw
Polska
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Beckman Coulter Ireland Inc.
Primary
Co. Clare
Ireland
ISO 13485:2003
The design and development, manufacture, distribution and customer support of clinical
chemistry, haematology, heterogenous immunoassay and flow cytometry in vitro diagnostic
devices.ISO 9k -
Beckman Coulter Ireland Inc.
Single
Co. Clare
Ireland
ISO 14001:2004
The design, development, manufacture, supply and customer support of clinical chemistry
and heterogenous immunoassay in-vitro diagnostic devices
Russia
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Hungary
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
The Netherlands
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
Beckman Coulter LLC
Secondary
Beckman Coulter Magyarorszag Kft
Secondary
Beckman Coulter Nederland B.V.
Secondary
Beckman Coulter S.A.S.
Secondary
93420 Villepinte
France
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
Beckman Coulter S.L.U.
Secondary
Barcelona
Spain
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
H - 1038 Budapest
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
Beckman Coulter S.r.l
Secondary
Beckman Coulter Slovenska republika s.r.
Secondary
COMPANY
STATE
Country
Scheme
Scope
Milano
Italy
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
85101 Bratislava
Slovak Repbulic
ISO 9001:2008
The sale, installation and service of products for biomedical testing, customer training and
distribution in India, Turkey and Russia
Republic of S Africa
ISO 9001:2008
The manufacture and distribution of diagnostic reagents; sales, installation and service of
biomedical testing products; and customer training
Beckman Coulter South Africa (Pty) Ltd
Primary
Beckman Coulter South Africa (Pty) Ltd
Secondary
Capetown
South Africa
ISO 9001:2008
The manufacture and distribution of diagnostic reagents; sales, installation and service of
biomedical testing products; and customer training
Beckman Coulter South Africa (Pty) Ltd
Secondary
Kloof
South Africa
ISO 9001:2008
The manufacture and distribution of diagnostic reagents; sales, installation and service of
biomedical testing products; and customer training
Beckman Coulter Unipessoal
Secondary
Lison
Portugal
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes
Beckman Coulter United Kingdom Limited
Secondary
High Wycombe,
Buckingham
United Kingdom
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central
administration of European sales and service orders including management of the distribution
processes.
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Beckman Coulter, Inc.
Secondary
Chaska
MN
USA
Beckman Coulter, Inc.
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
The design, development, manufacture, distribution and post sales support of in-vitro
diagnostic systems (hardware, software, reagents, calibrators, controls) and remanufacture of
hardware used in the diagnosis and/or managment of cancer,prenatal screening, immune
disease and autoimmune status, inflammatory disease, bone metabolism disorders, anemia,
diabetes, cardiac disease, endocrine disorders, blood analytes, transmissable agents,
sexually transmissable agents, fertility andpregnancy testing, and for therapeutic drug
monitoring.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
Beckman Coulter, Inc.
Secondary
Porterville
CA
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Beckman Coulter, Inc.
Secondary
Hebron
KY
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
Beckman Coulter, Inc.
Secondary
Irving
TX
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
Beckman Coulter, Inc.
Secondary
Danvers
MA
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
Beckman Coulter, Inc.
Secondary
Takeley, Essex
United Kingdom
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
COMPANY
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Beckman Coulter, Inc.
Primary
Brea
CA
USA
EN ISO 13485:2012
The design, development, manufacture, sale, distribution, installation and service of products
for biomedicaltesting.
Beckman Coulter, Inc.
Single
Porterville
CA
USA
ISO 9001:2008
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Secondary
Secondary
Indianapolis
Indianapolis
Miami
IN
IN
FL
USA
USA
USA
The manufacture of printed circuit boards.
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Profile
Type
Secondary
Secondary
Secondary
Primary
Secondary
Secondary
Primary
CITY
Hialeah
Hialeah
Florence
Brea
Indianapolis
Indianapolis
Brea
STATE
FL
FL
KY
CA
IN
IN
CA
Country
USA
USA
USA
USA
USA
USA
USA
Scheme
Scope
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
EN ISO 13485:2012
MD Scope: The Design and Development, Manufacture, Installation, and Service of
Automated Systems and Components for Sample Preparation in the Clinical
Marketplace.ISO9K Scope: The Design and Development, Manufacture, Installation, Service,
and Custom Integration of Automated Systems and Consumables for Industrial Use and
Biomedical Research and Testing.
EN ISO 13485:2012
MD Scope: The Design and Development, Manufacture, Installation, and Service of
Automated Systems and Components for Sample Preparation in the Clinical
Marketplace.ISO9K Scope: The Design and Development, Manufacture, Installation, Service,
and Custom Integration of Automated Systems and Consumables for Industrial Use and
Biomedical Research and Testing.
EN ISO 13485:2012
MD Scope: The Design and Development, Manufacture, Installation, and Service of
Automated Systems and Components for Sample Preparation in the Clinical
Marketplace.ISO9K Scope: The Design and Development, Manufacture, Installation, Service,
and Custom Integration of Automated Systems and Consumables for Industrial Use and
Biomedical Research and Testing.
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, and Distribution of Cytometry
Analyzers, Reagents, and Quality Controls used in Flow Cytometry and Blood Component
Determinations for Patient Management and Monitoring of Disease States andand Immunity.
EN ISO 13485:2012: The Design and Development, Manufacture, Installation, Service, and
Remanufacture of Cytometry Systems, Reagents and Controls used in Cellular Analysis,
Patient Management, Monitoring of Disease States and Immunity.
CMDCAS: The Design and Development, Manufacture, Service, and Distribution of Cytometry
Analyzers, Reagents, and Quality Controls used in Flow Cytometry and Blood Component
Determinations for Patient Management and Monitoring of Disease States andand Immunity.
EN ISO 13485:2012: The Design and Development, Manufacture, Installation, Service, and
Remanufacture of Cytometry Systems, Reagents and Controls used in Cellular Analysis,
Patient Management, Monitoring of Disease States and Immunity.
Beckman Coulter, Inc.
Secondary
Miami
FL
USA
ISO 13485/CMDCAS
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Installation, Service and Customer
Support of Particle Characterization Systems, and the Design, Development, Manufacture
and Service of Cytometry Systems for Research Use Only.
Beckman Coulter, Inc.
Secondary
Miami
FL
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Installation, Service and Customer
Support of Particle Characterization Systems, and the Design, Development, Manufacture
and Service of Cytometry Systems for Research Use Only.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Profile
Type
Secondary
Secondary
CITY
Hialeah
Hialeah
STATE
FL
FL
Country
USA
USA
Scheme
Scope
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, and Distribution of Cytometry
Analyzers, Reagents, and Quality Controls used in Flow Cytometry and Blood Component
Determinations for Patient Management and Monitoring of Disease States andand Immunity.
EN ISO 13485:2012: The Design and Development, Manufacture, Installation, Service, and
Remanufacture of Cytometry Systems, Reagents and Controls used in Cellular Analysis,
Patient Management, Monitoring of Disease States and Immunity.
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, and Distribution of Cytometry
Analyzers, Reagents, and Quality Controls used in Flow Cytometry and Blood Component
Determinations for Patient Management and Monitoring of Disease States andand Immunity.
EN ISO 13485:2012: The Design and Development, Manufacture, Installation, Service, and
Remanufacture of Cytometry Systems, Reagents and Controls used in Cellular Analysis,
Patient Management, Monitoring of Disease States and Immunity.
Beckman Coulter, Inc.
Secondary
Florence
KY
USA
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, and Distribution of Cytometry
Analyzers, Reagents, and Quality Controls used in Flow Cytometry and Blood Component
Determinations for Patient Management and Monitoring of Disease States andand Immunity.
EN ISO 13485:2012: The Design and Development, Manufacture, Installation, Service, and
Remanufacture of Cytometry Systems, Reagents and Controls used in Cellular Analysis,
Patient Management, Monitoring of Disease States and Immunity.
Beckman Coulter, Inc.
Secondary
Indianapolis
IN
USA
ISO 9001:2008
ISO 9001: The Design and Development, Manufacture, Remanufacture, Service, Installation
and Distribution of Instruments, Components, Reagents, Calibrators, Controls, and other
Consumables for Laboratory and Research Use as well as providing Genomic
Beckman Coulter, Inc.
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 9001:2008
The design, development, manufacture, sale, distribution, installation and service of products
for biomedicaltesting.
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Beckman Coulter, Inc.
Beckman Coulter, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Secondary
Hebron
Carlsbad
KY
CA
USA
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Profile
Type
Secondary
Secondary
Secondary
Secondary
CITY
Chaska
Chaska
Chaska
Irving
Secondary
Danvers
Becton Dickinson and Company
Single
Co. Louth
Becton Dickinson and Company, BD Medical
Single
Franklin Lakes
Becton, Dickinson and Company
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Primary
Franklin Lakes
STATE
MN
MN
MN
TX
MA
NJ
NJ
Country
Scheme
Scope
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
USA
ISO 13485/CMDCAS
CMDCAS: The Design and Development, Manufacture, Service, Installation, and Distribution
of Automated Instruments, Reagents, Calibrators, Controls, and other Consumables for use in
In-Vitro Diagnostic Medical DevicesEN ISO 13485:2012: The Design and Development,
Manufacture, Remanufacture, Service, Installation, and Distribution of Automated
Instruments, Reagents, Calibrators, Controls, and other Consumables for use in In-Vitro
Diagnostic Medical Devices
Ireland
ISO 14001:2004
USA
I.S.EN ISO13485:2012
The Manufacture and Distribution of Diabetes Drug Delivery Syringes, Diabetes Drug Delivery
Safety Pen Needles, Diabetes Drug Delivery Pen Needles and Lancets.
ISO 13485/CMDCAS
MD/CM Scope: The Design, Manufacture and Distribution of Sterile and Non-Sterile Needles,
Syringes, Pre-Filled Syringes, Needleless Access Devices, Catheters and Catheter
Accessories forVascular Access, Drainage, Infusion and Epidural use, Anesthesia, Radiology
and Biopsy Kits, Trays and Accessories, and Closed System Transfer Devices. (ISO9K
ending only: Specialty Plastic Containers for the Collection and Transport of
HealthcareWaste.)
USA
USA
USA
USA
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The manufacture of blood lancets, sterile and non sterile hypodermic needles and syringes
and needle components for syringes
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Becton, Dickinson and Company
Single
Canaan
CT
USA
EN ISO 13485:2012
The Manufacture of Sterile and Non-Sterile, High and Low Volume Hypodermic Syringes,
Syringe Components and IV Cannula Products.
Becton, Dickinson and Company
Single
Co. Dublin
Ireland
EN ISO 13485:2012
The Manufacture, Packaging and Sterilization of Insulin Delivery Systems and Blood Lancing
Accessories.
Becton, Dickinson and Company (BD)
Single
Sumter
USA
EN ISO 13485:2012
The manufacture, molding and irradation sterilization of disposable medical devices for use in
blood collection and laboratory services.
EN ISO 13485:2012
The molding and manufacture of sterile and non-sterile blood collection devices, urine
collection devices, cell preparation tubes, anaerobic specimen collection devices and needle
holders. The provision of intra-company label printing and irradiationsterilization services in
accordance with ISO 11137.
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture and Distribution of preanalytical products
including sterile and non-sterile blood / urine collection devices, sterile cell preparation
devices, anaerobic specimen collectiondevices, venting unit sub-assemblies, blood collection
needles, administration sets, microcollection devices and lancets.
COMPANY
Becton, Dickinson and Company (BD)
Single
Broken Bow
SC
NE
Becton, Dickinson and Company (BD)
Single
Franklin Lakes
Becton, Dickinson and Company Limited
Single
Co. Dublin
Ireland
ISO 13485/CMDCAS
The manufacture and distribution of medical devices for drug transfer, medical components,
non-active medical devices and diagnostic products.
Becton, Dickinson and Company Limited
Single
Co. Louth
Ireland
EN ISO 13485:2012
The manufacture and distribution of blood lancets, insulin delivery system accessories, sterile
and non-sterile hypodermic needles and syringes, prefilled syringes and components for
syringes.
Bern Optics, Inc
Single
Westfield
MA
USA
EN ISO 13485:2012
The manufacture and distribution of optical components and assemblies for medical device
equipment and instrument applications.
Bijur Delimon International
Single
Kinston
NC
USA
ISO 9001:2008
Bio Medical Research, Ltd
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
MD and CMDCAS Scope: The design, maufacture and distribution of powered stimulators,
biofeedback devices, electrodes, lead wires and orthosis devices for the Gastroenterology &
Urology, Neurology and Physical Medicine areas.
BioCheck, Inc.
Single
Foster City
CA
USA
ISO 13485:2003
The design, manufacture and distribution of ELISA test kits for Tumor markers, cardiac
markers, hormone, fertility, TORCH, infectious disease, other analytes (IgE and Ferritin) and
contract development and manufacturing.
Biohelix Corporation
Single
Beverly
MA
USA
ISO 13485:2003
The Design and Development, and Manufacture of Helicase Dependent Amplification (HDA)
In-Vitro Diagnostic Components.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
NJ
USA
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The Design, Manufacture and Distribution of Lubrication Systems and Components.
4/10/2015
Profile
Type
CITY
Single
Burlington, Ontario
Biomedical Structures LLC
Secondary
Warwick
Biomedical Structures LLC
Primary
Warwick
Single
Secondary
COMPANY
Biolab Equipment Ltd.
Biomnis Irealand (Logistics Division)
BioTek Instruments GmbH
STATE
Country
Scheme
Scope
Canada
ISO 13485/CMDCAS
Design, Manufacturing, Installation and Service of Water Purification System for Medical
Applications.ISO 9001 Scope: Design, Contract Development, Manufacturing, Installation and
Service of Water Purification System for Industrial, Commercial and Pharmaceutical
Applications.
RI
USA
ISO 13485:2003
Design, Development, and Manufacture of textile and composite materials for the biomedical /
biosurgical / tissue engineering markets. Biomedical Structures is a contract design,
development, and manufacturing firm.
RI
USA
ISO 13485:2003
Design, Development, and Manufacture of textile and composite materials for the biomedical /
biosurgical / tissue engineering markets. Biomedical Structures is a contract design,
development, and manufacturing firm.
Dublin 18
Ireland
ISO 9001:2008
Transportation of pathological specimens to Healthcare Settings
Bad Friedrichshall
Germany
EN ISO 13485:2012
ISO13485 : The Design, Manufacture, Distribution, Service and Installation of in-vitro
diagnostic Microplate Readers, Washers, Dispensers, Stackers, Pipetting Work Stations and
Accessories.
Primary
Winooski
VT
USA
EN ISO 13485:2012
ISO 13485 Scope: The Design, Manufacture, Distribution, Service and Installation of in-vitro
diagnostic Microplate Readers, Washers, Dispensers, Stackers, Pipetting Work Stations and
Accessories.ISO9001: The design, manufacture, distribution, service and installation of
research and development and in-vitro diagnostic products.
Bluegrass Supply Chain Services
Single
Bowling Green
KY
USA
ISO 9001:2008
The provision of quality inspection, sorting, containment, and rework services to commercial
and automotive manufacturers and distributors.
Bob Johnson Associates, Inc.
Single
Leominster
MA
USA
EN ISO 13485:2012
The Manufacture and Distribution of Permanent Magnet Components for the Medical Device
Industry
Boekel Scientific
Single
Feasterville
PA
USA
EN ISO 13485:2012
ISO 13485 Scope: The Design, Manufacture and Distribution of Active Blood and Plasma
Warming Devices.9K Scope: The Design, Manufacture and Distribution of Life Science and
General Laboratory Equipment Servicing the Medical, Pharmaceutical, Biotech and Life
Science Markets.
Bon Secours Hospital
Single
Co. Galway
Ireland
EN ISO 13485:2012
The Provision of Disinfection and Sterilisation Services for Re-usable Invasive Medical
Devices.
Bonding Source
Single
Nashua
NH
USA
ISO 9001:2008
Value Added Re-Seller of Epoxies and Related items for the Microelectronics and
RF/Microwave Industries
Bovie Screen Process Printing Co., Inc.
Single
Bow
NH
USA
ISO 9001:2008
The Provision of Manufactured Printed Products such as Membrane Switches, Overlays,
Decals, Labels and Direct Product Markings.
BioTek Instruments, Inc
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Boyd Technologies, Inc.
Single
South Lee
MA
USA
EN ISO 13485:2012
MD Scope: The Manufacturing, Converting, Packaging, and Distribution of Advanced Flexible
Roll-to-Roll Materials for the Medical Device Industry.ISO9K Scope: The Manufacturing,
Converting, Packaging, and Distribution of Advanced Flexible Roll-to-Roll Materials.
Boyle Transportation
Single
Billerica
MA
USA
ISO 9001:2008
Motor carrier transportation of shipments that require extensive safety and security
Brantner & Associates, Inc.
Primary
El Cajon
CA
USA
ISO 9001:2008
Design and Manufacture of Electrical and Fiber Optic Connectors, Cable Assemblies and
System Solutions for Harsh Subsea Environments for Military and Commercial Applications.
Brantner & Associates, Inc.
Secondary
El Cajon
CA
USA
ISO 9001:2008
Design and Manufacture of Electrical and Fiber Optic Connectors, Cable Assemblies and
System Solutions for Harsh Subsea Environments for Military and Commercial Applications.
Brantner & Associates, Inc.
Secondary
El Cajon
CA
USA
ISO 9001:2008
Design and Manufacture of Electrical and Fiber Optic Connectors, Cable Assemblies and
System Solutions for Harsh Subsea Environments for Military and Commercial Applications.
Bristol Tape Corporation
Single
Fall River
MA
USA
ISO 9001:2008
Converter of pressure sensitive and non-sensitive films, foils and tapes
Brivant Limited
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
Broadcast Microwave Services, Inc.
Single
Poway
CA
USA
ISO 9001:2008
Design and Manufacture of Microwave Communications Equipment for the Television
Broadcast, Surveillance, Homeland Security and Law Enforcement Industries.
Brooks Automation
Single
Fremont
CA
USA
ISO 9001:2008
Design, manufacture, installation, service and technical support of integrated automation
solutions for the semiconductor, green and life sciences industries.
BWT Pharma & Biotech Ltd.
Single
Dublin
Ireland
EN ISO 13485:2012
MD scope: The Design, Manufacture, Installation, Commissioning and Servicing of Water
Purification Systems for Use in Haemo Dialysis Treatment.9k scope: The Design,
Manufacture, Installation, Commissioning and Servicing of Water Purification Systems.
COMPANY
C.J. Electrical Contracting Inc.
Single
Medford
NY
USA
TL 9000 R5.0/5.0
Calex Manufacturing Co., Inc.
Primary
Concord
CA
USA
ISO 9001:2008
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
CMDCAS & MD Scope: The design, manufacture & distribution of interventional guide wires
and components. The coating and packaging of sterile and non-sterile interventional devices
including catheters.
TL9000-V Scope: A Full Service Provider of Engineering, Furnishing and Installation for the
Telecommunications Industry Specializing in Power AC/DCand Network Systems for the
following Service Categories: 7.1.1 Installation and 7.2.1.1 Fix Network Engineering.ISO9K
Scope: A Full Service Provider of Engineering, Furnishing and Installation for the
Telecommunications Industry Specializing in Power AC/DC and Network Systems.
The design, manufacture and sales of DC/DC, AC/DC Power Conversion Products,
Instrumentation Products and LED Drivers
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Caliper Life Sciences,
Secondary
Hopkinton
MA
USA
ISO 9001:2008
The Design, Manufacture, Sales and Support of Laboratory Automation Equipment and
Services.
Caliper Life Sciences,
Primary
Hopkinton
MA
USA
ISO 9001:2008
The Design, Manufacture, Sales and Support of Laboratory Automation Equipment and
Services.
Caliper Life Sciences, Inc.
Primary
Hopkinton
MA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Systems for evaluation of
DNA fragments for diagnosis of disease, infection and abnormalities.
Caliper Life Sciences, Inc.
Secondary
Hopkinton
MA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Systems for evaluation of
DNA fragments for diagnosis of disease, infection and abnormalities.
Cambridge International Systems, Inc.
Single
Arlington
VA
USA
ISO 9001:2008
Cambridge Isotope Laboratories, Inc.
Secondary
Andover
MA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Neonatal Standard Reference
Material for use in Screening, Diagnosis and Monitoring of Metabolic Disorders including
Phenylketonuria.
Cambridge Isotope Laboratories, Inc.
Primary
Tewksbury
MA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Neonatal Standard Reference
Material for use in Screening, Diagnosis and Monitoring of Metabolic Disorders including
Phenylketonuria.
Candelis, Inc.
Single
Newport Beach
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of Picture Archiving and Communications Systems
(PACS), Radiology Information Systems (RIS), RT, Radiology and Mammography Viewers.
Cannon Fabrication Company
Single
Milroy
IN
USA
ISO 9001:2008
Caragh Precision
Single
Galway
Ireland
EN ISO 13485:2012
Secondary
Export
USA
ISO 13485:2003
The manufacture of general, non-active, non-implantable medical devices such as cervical
spatulas and endoscope accessories; The manufacture of general active medical devices
such as CPAP accessories and respiratory devices accessories; Themanufacture of in vitro
diagnostic instruments such as reaction vessels, cuvettes and pipettes.
ISO 13485:2003
The manufacture of general, non-active, non-implantable medical devices such as cervical
spatulas and endoscope accessories; The manufacture of general active medical devices
such as CPAP accessories and respiratory devices accessories; Themanufacture of in vitro
diagnostic instruments such as reaction vessels, cuvettes and pipettes.
COMPANY
Carclo Technical Plastics
Carclo Technical Plastics
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Tucson
PA
AZ
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Design and Provisioning of National Security and Defense Services.
The manufacture of sound deadening products, die cut parts and assemblies.
MD Scope: The manufacture of precision machined components and products for medical
devices including passivation, cleaning and cleanroom manufacturing.ISO9K Scope: The
manufacture of precision machined components.
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Carclo Technical Plastics
Secondary
Latrobe
PA
USA
ISO 13485:2003
The manufacture of general, non-active, non-implantable medical devices such as cervical
spatulas and endoscope accessories; The manufacture of general active medical devices
such as CPAP accessories and respiratory devices accessories; Themanufacture of in vitro
diagnostic instruments such as reaction vessels, cuvettes and pipettes.
Carclo Technical Plastics
Secondary
Tucson
AZ
USA
ISO 13485:2003
The manufacture of general, non-active, non-implantable medical devices such as cervical
spatulas and endoscope accessories; The manufacture of general active medical devices
such as CPAP accessories and respiratory devices accessories; Themanufacture of in vitro
diagnostic instruments such as reaction vessels, cuvettes and pipettes.
Carclo Technical Plastics
Primary
Latrobe
PA
USA
ISO 13485:2003
The manufacture of general, non-active, non-implantable medical devices such as cervical
spatulas and endoscope accessories; The manufacture of general active medical devices
such as CPAP accessories and respiratory devices accessories; Themanufacture of in vitro
diagnostic instruments such as reaction vessels, cuvettes and pipettes.
Cardinal Manufacturing Company
Single
Louisville
KY
USA
ISO 9001:2008
The Manufacture of Roll Formed Shaped Products from Customer Specifications.
Cardio3 BioSciences SA/NV
Single
Mont-Saint-Guibert
Belgium
ISO 13485:2003
The design and development, manufacture and distribution of sterile cardiovascular catheters
Cardiox Corporation
Single
Columbus
OH
USA
EN ISO 13485:2012
The design, manufacture and distribution of active diagnostic medical devices that utilize
detection of indicator dyes to evaluate circulatory and metabolic abnormalities.
Carlsbad International Export Inc.
Single
Carlsbad
CA
USA
ISO 13485:2003
Manufacture and distribution of consumable medical accessories for ventilation products.
Carolina Laser Cutting Inc.
Single
Greensboro
NC
USA
ISO 9001:2008
The provision of high precision CO2 laser cutting and sheet metal fabrication services.
Caspers Distribution Company
Single
Tampa
FL
USA
ISO 14001:2004
Distribution of restaurant food and supplies
CASWELL, INC.
Single
New Taipei City
Taiwan
TL 9000 R5.0/5.0
ISO 9001 Scope:Design and Sales of Server, Network Related Server, and M/B & NIC.TL
9000-H Scope:Design and Sales of Server, Network Related Server, and M/B & NIC for the
Product Category: 8.2.3-High Complexity Electronic Assemblies.
Cervical Check
Single
Co Limerick
Ireland
ISO 9001:2008
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The management of the National Cervical Screening Programme
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Charles Industries, Ltd.
Primary
Rolling Meadows
IL
USA
TL 9000 R5.5/R5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial
products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Canton
MO
USA
TL 9000 R5.5/R5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial
products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Casey
IL
USA
TL 9000 R5.5/R5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial
products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Marshall
IL
USA
TL 9000 R5.5/R5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial
products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Rantoul
IL
USA
TL 9000 R5.5/R5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial
products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures.
COMPANY
Charng Huah Electronic Co., Ltd.
Single
Taoyuan Hsien
Charter Medical Ltd
Single
Winston Salem
CHD Bioscience, Inc.
Primary
CHD Bioscience, Inc.
Scope
ISO9K Scope: Surface Mount Technology (SMT), Insertion, Assembly of Printed Circuit Board
and Finished Products.TL 9000-H Scope: Surface Mount Technology (SMT), Insertion,
Assembly of Printed Circuit Board and Finished Products, Product Category: 8.2.4-Very High
Complexity Subassemblies - Direct Suppliers.
Taiwan, R.O.C.
TL 9000 R5.0/5.0
NC
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of Medical Devices used in collection, storage and
processing of blood and blood components to include tubing, connectors, syringes, mesh
filters and bags.The manufacture and distribution of foam, felt and knit components for
medical applications.The design, manufacture and distribution of disposable bio-containers.
Fort Collins
CO
USA
EN ISO 13485:2012
The design and development of chemical solutions for the disinfection and sterilization of
reusable medical devices
Secondary
Fort Collins
CO
USA
EN ISO 13485:2012
The design and development of chemical solutions for the disinfection and sterilization of
reusable medical devices
Chromatics, Inc.
Single
Bethel
CT
USA
ISO 9001:2008
The Design and Manufacture of Fluoropolymer Color Concentrates and Compounds.
Circuit Technology, Inc
Single
Merrimack
NH
USA
ISO 9001:2008
Sales and Production of Electronic Assemblies
ClearFlow, Inc.
Single
Anaheim
CA
USA
ISO 13485/CMDCAS
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design, manufacture and distribution of sterile, disposable chest drainage catheters and
systems.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Cliniqa Corporation
Secondary
San Marcos
CA
USA
ISO 13485/CMDCAS
The design, development and manufacture of in-vitro diagnostic controls, calibrators, raw
materials, reagents and kits for the diagnosis, management, detection of blood analytes,
blood components, cardiac markers, cancer, therapeutic drug monitoring,and drugs of abuse.
Cliniqa Corporation
Primary
San Marcos
CA
USA
ISO 13485/CMDCAS
The design, development and manufacture of in-vitro diagnostic controls, calibrators, raw
materials, reagents and kits for the diagnosis, management, detection of blood analytes,
blood components, cardiac markers, cancer, therapeutic drug monitoring,and drugs of abuse.
Clover Environmental Solutions
Single
Oglesby
IL
USA
ISO 9001:2008
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other
Small Electronic Devices
Clover Environmental Solutions
Single
Mexicali B.C.
México
ISO 14001:2004
Receiving, processing, warehousing and distribution of recycled printer cartridges, cell phones
and other small electronic devices.
Clover Environmental Solutions
Single
Oglesby
USA
ISO 14001:2004
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other
Small Electronic Devices
Clover Technologies Canada, ULC
Single
Ontario
Canada
ISO 9001:2008
Collection of recycled cartridges and warehousing and distribution of laser, inkjet, impact
printer cartridges and other printing related consumables.
Clover Technologies Group
Secondary
Ithaca
MI
USA
ISO 9001:2008
Design, Manufacturing, Remanufacturing and Distribution of Inkjet Cartridges and Other
Printing Related Consumables
Clover Technologies Group
Primary
Calexico
CA
USA
ISO 9001:2008
Warehousing and distribution of laser, inkjet, impact printer cartridges, wireless devices and
other printing related consumables.
Clover Technologies Group
Secondary
Calexico
CA
USA
ISO 9001:2008
Warehousing and distribution of laser, inkjet, impact printer cartridges, wireless devices and
other printing related consumables.
Clover Technologies Group
Primary
Ottawa
IL
USA
ISO 9001:2008
Design, manufacturing, and/or distribution of laser, inkjet, impact printer cartridges and other
printing related consumables.
Clover Technologies Group
Primary
Ithaca
MI
USA
ISO 9001:2008
Design, Manufacturing, Remanufacturing and Distribution of Inkjet Cartridges and Other
Printing Related Consumables.
Clover Technologies Group
Single
Plano
TX
USA
ISO 9001:2008
Warehousing and distribution of laser, inkjet, impact printer cartridges and other printing
related consumables and parts.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
IL
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Clover Technologies Group
Secondary
Oglesby
IL
USA
ISO 14001:2004
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other
Small Electronic Devices
Clover Technologies Group
Secondary
Oglesby
IL
USA
ISO 9001:2008
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other
Small Electronic Devices
Clover Technologies Group
Secondary
Ottawa
IL
USA
ISO 9001:2008
Design, manufacturing, and/or distribution of laser, inkjet, impact printer cartridges and other
printing related consumables.
Single
Farmingdale
NJ
USA
ISO 9001:2008
Collection, Design, Repair, Re-manufacturing and Distribution of printer parts.
Clover Telecom Asset Management, LLC.
Secondary
Irving
TX
USA
ISO 14001:2004
Repair and Return of Telecommunications Products.
Clover Telecom Asset Management, LLC.
Primary
Irving
TX
USA
ISO 14001:2004
Repair and Return of Telecommunications Products.
Coatings 2 Go, LLC
Single
Carlisle
MA
USA
EN ISO 13485:2012
CohuHD Costar, LLC.
Single
Poway
CA
USA
ISO 9001:2008
The Research, Design, Manufacture, Distribution, and Servicing of Cameras, Advanced Video
Products and Systems.
Combe Laboratories Inc.
Single
Rantoul
IL
USA
EN ISO 13485:2012
English Scope: Manufacturing of denture adhesive seals, feminine wipes, powder and liquid
feminine douches, and vaginal infection screening kits.Spanish Translated Scope: Fabricante
de almohadillas adhesivas para dentadura postiza, toallas femeninas, polvos y líquidos para
duchas femeninas y kits de prueba para infecciones vaginales.
Combe Products, Inc
Single
Naguabo
Puerto Rico
EN ISO 13485:2003
The manufacture and distribution of non-biological gels for vaginal use.
COMPANY
Clover Technologies Group, LLC
Compal Networking (Kunshan) Co., Ltd
Single
Kunshan
China
TL 9000 R5.0/5.0
Componentes Intel de Costa Rica S. A.
Secondary
Heredia
Costa Rica
ISO 9001:2008
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Manufacture and Distribution of Coatings for use in the Medical Device Industry.
ISO 9000 Scope: Production of Broadband Networking Equipment (Wireless Card, Gateway,
Access Point and High End Router).TL Scope-H: Production of Broadband Networking
Equipment (Wireless Card, Gateway, Access Point and High End Router for the Product
Category: 7.7.4 Electromechanical Assembly.
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
4/10/2015
Profile
Type
CITY
Componentes Intel de Costa Rica S. A.
Secondary
Componentes Intel de Costa Rica S.A.
COMPANY
Country
Scheme
Heredia
Costa Rica
ISO 14001:2004
The manufacturing of semiconductors.
Secondary
Heredia
Costa Rica
OHSAS 18001:2007
The manufacturing of semiconductors.
Computer Cite (CCITE)
Single
San Ramon
CA
USA
ISO 9001:2008
Provision of contract staffing services and special project services.
Computer Services Dept. of the CSIU
Single
Milton
PA
USA
ISO 9001:2008
Development, Sales, Training, and Support of Financial, Student and Tax Software for
Schools.
Comstock Industries
Single
Meredith
NH
USA
ISO 9001:2008
Manufacture of Ferrous and Non-Ferrous, Plastic and Polyurethane Products.
Comtran Cable, LLC
Single
South Attleboro
MA
USA
ISO 9001:2008
Design and Manufacture of Wire and Cable for Electrical, and Voice and Data
Communications Applications.
Contech Medical, Inc.
Single
Providence
RI
USA
I.S.EN ISO13485:2012
Controls for Automation
Primary
Taunton
MA
USA
EN ISO 13485:2012
MD Scope: The manufacture and distribution of components and assemblies for the medical
device industry.ISO9K Scope: The manufacture and distribution of components,
manufactured products and assemblies for various industries that include medical.
Controls for Automation
Secondary
Gilford
NH
USA
EN ISO 13485:2012
MD Scope: The manufacture and distribution of components and assemblies for the medical
device industry.ISO9K Scope: The manufacture and distribution of components,
manufactured products and assemblies for various industries that include medical.
Conventus Orthopaedics, Inc
Single
Maple Grove
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Non-Active Orthopaedic Implants and Associated
Accessories.
Core Sound Imaging, Inc.
Single
Raleigh
NC
USA
EN ISO 13485:2012
The Design, Development and Distribution of Web-Based Picture Archival and
Communications Systems (PACS), Including Software.
Core Technology Molding Corp
Single
Greensboro
NC
USA
ISO 9001:2008
The inspection, rework, assembly of secondary plastics and molding processes
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Contract Assembly and Packaging of OEM Medical Device Components and Assemblies.
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Trim, Form, BGA Reballing, J-Lead Attach, Lead Straightening, Lead Reconditioning,
Solderability Testing, Fine & Gross Leak Testing, Ionic Cleanliness Testing, X-Ray
Fluorescence Testing, Tape & Reel, Bake & Dry Packaging, Long Term Storage, Kitting,and
Robotic Hot Solder Dip of Electronic Devices, Including Component Preparation and
Termination Finish Conversion for RoHS Compliance, and the Elimination of Tin Whisker and
Gold Embrittlement Risks.
Corfin Industries LLC
Single
Salem
NH
USA
AS 9100 - C
Corning Incorporated
Single
Durham
NC
USA
EN ISO 13485:2012
Corning Life Sciences
Single
Durham
NC
USA
ISO 14001:2004
Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture Products.
Corning, Inc.
Single
Woburn
MA
USA
ISO 9001:2008
The Design and Manufacture of Products for Research Use Only in Life Sciences Research
Corning, Inc.
Single
Bedford
MA
USA
ISO 9001:2008
The Design and Manufacture of Products for Research use only in Life Sciences Research.
Cosman Medical, Inc.
Single
Burlington
MA
USA
ISO 13485/CMDCAS
Craftech Industries, Inc.
Single
Hudson
NY
USA
ISO 9001:2008
Fabrication of high performance fasteners and components.
Creation Technologies
Secondary
Milpitas
CA
USA
ISO 9001:2008
The provider of electronic manufacturing services and sustaining services.
Creation Technologies
Single
Milpitas
CA
USA
EN ISO 13485:2012
CRI-SIL Silicone Technologies, LLC
Single
Biddeford
ME
USA
ISO 9001:2008
Critical Care Diagnostics Inc.
Secondary
San Diego
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assay and Related
Controls for Professional Use.
Critical Care Diagnostics, Inc.
Primary
San Diego
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assay and Related
Controls for Professional Use.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The Design, Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture
Products.
The design and development, manufacture, servicing and distribution of RF Lesion generators
and associated sterile and non-sterile RF electrodes and injection needles for surgical use.
Manufacturing of electronic printed circuit board assemblies and system integration of printed
circuit board assemblies into finished electronic equipment.
Manufacturer and Delivery of Performance Elastomer Products and Services
4/10/2015
Profile
Type
CITY
Secondary
Dublin 4
Critical Process Filtration, Inc.
Single
Nashua
Croom Precision Medical Ltd
Single
Co. Limerick
CROSSTEX International, Inc.
Secondary
Hauppauge
CROSSTEX International, Inc.
Primary
CROSSTEX International, Inc.
COMPANY
Country
Scheme
Ireland
EN ISO 13485:2012
USA
ISO 9001:2008
Ireland
EN ISO 13485:2012
The manufacture of precision medical device components.
NY
USA
ISO 13485/CMDCAS
The Design and Manufacture of Surgical Face Masks, Examiniation Gloves, Disposable
Prophy Angles, Saliva Ejectors, Evacuator tips and Non-Sterile Single-Use Barrier Products
for the Healthcare Industry
Hauppauge
NY
USA
ISO 13485/CMDCAS
The Design and Manufacture of Surgical Face Masks, Examiniation Gloves, Disposable
Prophy Angles, Saliva Ejectors, Evacuator tips and Non-Sterile Single-Use Barrier Products
for the Healthcare Industry
Secondary
Sharon
PA
USA
ISO 13485/CMDCAS
The Design and Manufacture of Surgical Face Masks, Examiniation Gloves, Disposable
Prophy Angles, Saliva Ejectors, Evacuator tips and Non-Sterile Single-Use Barrier Products
for the Healthcare Industry
CSA Group
Single
Cleveland
OH
USA
CSA-Z1000:2006
Testing and Certification of Products/ Standards
CSA Group
Single
Richmond, British
Columbia
Canada
CSA-Z1000:2006
Product Testing and Product Certification
CSA Group
Single
Toronto
ON
Canada
CSA-Z1000:2006
Product Testing and Certification
CSA Group
Primary
Rexdale
ON
Canada
ISO 9001:2008
The provision of financial management and operational management support services for
CSA Group.
CSA Group
Secondary
Cleveland
OH
USA
ISO 9001:2008
The provision of financial management and operational management support services for
CSA Group.
CSA Group
Single
Pointe Claire, Quebec
Canada
CSA-Z1000:2006
Critical Diagnostics Limited
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
NH
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assay and Related
Controls for Professional Use.
Manufacture and Distribution of Filter Systems for diverse industries including Medical
Devices.
Product Testing and Certification.
4/10/2015
Profile
Type
CITY
CSA Group
Single
Point Claire, Quebeq
CSA Group
Single
Irvine
CSA Group
Single
Irvine
CSA Group
Single
Richmond, British
Columbia
CSA Group
Single
Toronto
CSA Group
Single
Cleveland
CSA International
Single
CSA International
COMPANY
Country
Scheme
Canada
ISO 14001:2004
Product Testing and Certification.
CA
USA
ISO 14001:2004
Product Testing and Product Certification
CA
USA
CSA-Z1000:2006
Product testing and product certification.
Canada
ISO 14001:2004
Product Testing and Product Certification
ON
Canada
ISO 14001:2004
Product Testing and Certification
OH
USA
ISO 14001:2004
Testing and Certification of Products/ Standards
Alberta
Canada
CSA-Z1000:2006
Product testing and product certification.
Single
Alberta
Canada
ISO 14001:2004
Product testing and product certification.
CTT, Inc.
Single
Sunnyvale
CA
USA
AS 9100 - C
Design and manufacture of Microwave Power Amplifiers, Frequency Converters, Frequency
Multipliers, Transmitters, Transceivers and Subsystems within the Frequency Range of
300MHz to 110GHz using MIC Hybrid Technology.
Cubbison Company
Single
Youngstown
OH
USA
ISO 9001:2008
Design and manufacture of custom product identification solutions (e.g. Cut Film Graphics,
Domed Labels, Overlays, Label Kits, Industrial Labels and Metal Nameplates).
Cugreen Metal Tech. Co., Ltd.
Single
Taoyuan County
Taiwan, R.O.C.
ISO 9001:2008
ISO9K: Design and development, manufacturing and sales for copper oxide and copper
carbonate, materials for copper plating process of PCB and semi-conductor industries.
Cugreen Metal Tech. Co., Ltd.
Single
Taoyuan County
Taiwan, R.O.C.
QC 080000
IECQ: Design and development, manufacturing and sales for copper oxide and copper
carbonate, materials for copper plating process of PCB and semi-conductor industries,
applicable to European Directive 2011/65/EU and customer specified requirements.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
COMPANY
Cuprime Material Co. Ltd
Profile
Type
CITY
Single
Taoyuan County
STATE
MN
Country
Scheme
Scope
Taiwan, R.O.C.
ECCB HSPM
Manufacture and sales of high purity bare copper bar and wire for cords and cables, including
8.0 mm and 2.6 mm sizes.
USA
ISO 13485/CMDCAS
CMDCAS Scope: The design, manufacture and distribution of implantable and external pulse
generators, programmer / external systems, implantable and temporary electrode / leads,
surgical tool kits, and accessory kits.MD Scope: The design, manufacture and distribution of
implantable and external pulse generators, programmer / external systems, implantable and
temporary electrode / leads, surgical tool kits, and accessory kits for the treatment of
cardiovasculardisease
Ireland
I.S.EN ISO13485:2012
CVRx, Inc.
Single
Minneapolis
CWS-boco
Single
Dublin 22
Cytonome/ST, LLC
Single
Boston
MA
USA
ISO 9001:2008
CytoTest Inc.
Single
Rockville
MD
USA
EN ISO 13485:2012
DALTON MANUFACTURING COMPANY INC
Single
AMESBURY
MA
USA
ISO 9001:2008
The manufacture, packaging and distribution of sterile and non-sterile surgical supplies,
gowns, wound dressings, drapes, including sterile procedure packs
Design, Manufacture, Sales, and Service of Cell Purification Systems and Technologies for
BioMedicine, BioIndustry and BioScience.
MD and ISO9K Scope: The design, manufacture, and distribution of DNA fluorescence in situ
hybridization (FISH) probes for the diagnosis of chromosomal abnormalities.
The machining of customer designed parts and assemblies including medical.
USA
EN ISO 13485:2012
MD Scope: The repair, exchange, sale, end of life support, and logistics services for
electronic, computer, communications, medical equipment and components.ISO9K Scope:
The repair, exchange, sale, end of life support, and logistics services for electronic, computer,
and communication equipment and components.
Dublin 17
Ireland
EN ISO 13485:2012
MD Scope: The service & repair of active medical imaging equipment.ISO9K Scope: The
repair, exchange, sale and support of equipment as well as logistic services for the electronic,
communication, medical and renewable energy industries.
Secondary
Mexicali B.C.
Mexico
ISO 9001:2008
The Collection, Processing, Warehousing, Manufacturing, Re-manufacturing and Distribution
of laser recycled printer cartridges and related consumables; processing, warehousing and
distribution of cell phones and other small electronic devices.
Dataproducts Imaging Solutions SA de CV
Secondary
Mexicali B.C.
Mexico
ISO 9001:2008
The Collection, Processing, Warehousing, Manufacturing, Re-manufacturing and Distribution
of laser recycled printer cartridges and related consumables; processing, warehousing and
distribution of cell phones and other small electronic devices.
Dataproducts Imaging Solutions SA de CV
Primary
Mexicali B.C.
Mexico
ISO 9001:2008
The Collection, Processing, Warehousing, Manufacturing, Re-manufacturing and Distribution
of laser recycled printer cartridges and related consumables; processing, warehousing and
distribution of cell phones and other small electronic devices.
Single
Dayton
USA
ISO 9001:2008
Forging, heat treating and machining of steel and alloys.
Data Exchange Corp
Single
Camarillo
Data Exchange Europe Ltd
Single
Dataproducts Imaging Solutions SA de CV
Dayton Forging and Heat Treating
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
OH
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Deco-Chem Inc
Single
Mishawaka
IN
USA
ISO 9001:2008
Delfi Medical Innovations Inc.
Single
Vancouver, BC
Canada
ISO 13485/CMDCAS
The Design, Development, Manufacture, and Servicing of Tourniquet Systems. The Design,
Development, and Manufacture of Sterile and Non-Sterile Tourniquet Cuffs.
Dell (Chengdu) Company Limited
Secondary
Chengdu, Sichuan
China
ISO 9001:2008
Manufacture and Supply of Computers, and Associated Hardware and Software and Related
Management Activities.
Dell (Chengdu) Company Limited
Secondary
Chengdu, Sichuan
China
ISO 14001:2004
Manufacture and Supply of Computers and Technology Products.
Dell (Chengdu) Company Limited
Secondary
Chengdu, Sichuan
China
OHSAS 18001:2007
Manufacture and Supply of Computers and Technology Products.
Dell (China) Co. Ltd (CCC5)
Secondary
Xiamen
China
ISO 9001:2008
Manufacture, Sales, Sales Operations, Customer Service & Support and Supply of
Computers, and Associated Hardware and Software Related Activities
Dell (China) Co. Ltd.
Secondary
Fujian
China
ISO 9001:2008
Manufacture and Supply of Computers, Server, Storage, Associated Hardware, Software,
Related Activities and All Provisions of Sales, Sales Operations, Customer Service, Support,
and Customer Care for Computers, Server, Storage, Technology Productsand Solutions.
Dell (China) Co. Ltd. (CCC2)
Secondary
Fujian
China
ISO 14001:2004
The manufacture and supply of computers, servers, storage and associated hardware and
software.
Dell (China) Co., Ltd.
Secondary
Dalian
China
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell (China) Co., Ltd.
Secondary
Fujian
China
OHSAS 18001:2007
Dell (China) Co., Ltd.
Secondary
Beijing
China
ISO 9001:2008
All Provisions of Customer Service, Support and Sales Operations for Computers,
Technology Products and Solutions
Dell (Taiwan) B.V., Taiwan Branch
Secondary
Taipei
Taiwan
ISO 9001:2008
The Design, Development, Customer Services and Supporting Functions of Computers and
Technology Products and Services
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Manufacture of Ink
The manufacture and supply of computers, servers, storage and associated hardware and
software.
4/10/2015
Profile
Type
CITY
Dell (Xiamen) Co. Ltd.
Secondary
Dell (Xiamen) Co. Ltd. (CCC4)
COMPANY
Country
Scheme
Fujian
China
ISO 9001:2008
Secondary
Fujian
China
OHSAS 18001:2007
The manufacture and supply of computers, servers, storage and associated hardware and
software.
Dell (Xiamen) Co. Ltd. (CCC4)
Secondary
Fujian
China
ISO 14001:2004
The manufacture and supply of computers, servers, storage and associated hardware and
software.
Dell A/S
Secondary
Copenhagen
Denmark
ISO 9001:2008
All Provisions of Customer Service and Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell AB
Secondary
Solna
Sweden
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell AS
Secondary
Oslo
Norway
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Asia Pacific Sdn. Bhd.
Secondary
Penang
Malaysia
ISO 9001:2008
Regional Procuement and Information Technology Services, Regional Centre for Engineering,
Manufacturing, Fulfilment & Delivery, Logistics and Quality Management. Global
Manufacturing for Computers, Technology Products and Services.
Dell Asia Pacific Sdn. Bhd. (APCC2)
Secondary
Penang
Malaysia
OHSAS 18001:2007
Dell Asia Pacific Sdn. Bhd. (APCC2)
Secondary
Penang
Malaysia
ISO 14001:2004
The manufacture and supply of computers and technology products.
Dell Australia Pty Limited
Secondary
Sydney, New South
Wales
Australia
ISO 9001:2008
Sales, Sales Operations, Customer Service and Support for a range of desktop, server and
notebook computers and associated peripherals.
Dell B.V.
Secondary
AK Amsterdam
Netherlands
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Canada
Secondary
North York, Ontario
Canada
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Manufacture and Supply of Computers, Server, Storage, Associated Hardware, Software,
Related Activities and All Provisions of Sales, Sales Operations, Customer Service, Support,
and Customer Care for Computers, Server, Storage, Technology Productsand Solutions.
Manufacture and supply of computers and technology products.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Single
Wallingford
CT
USA
EN ISO 13485:2012
Design and Development, Manufacture, Test, Service and Distribution of Software for Secure
Storage and Retrieval of Medical Patient Data and Image Files
Dell Commerce Systems (DCS)
Secondary
Round Rock
TX
USA
ISO 9001:2008
Software design, development and support.
Dell Computadores do Brazil Ltda
Secondary
Hortolândia, SP 13.184654
Brazil
ISO 14001:2004
The manufacture and supply of computers and technology products.
Dell Computadores do Brazil Ltda.
Secondary
Hortolândia, SP
Brazil
OHSAS 18001:2007
Dell Computadores do Brazil Ltda.
Secondary
Hortolândia, SP 13.184654
Brazil
ISO 9001:2008
Manufacture, Fulfillment & Delivery, Re-Furbishment and All Provisions of Customer Service,
Support and Customer Care for Computers, Technology Products and Solutions
Dell Computadores do Brazil Ltda.
Secondary Eldorado do Sul - CEP
Brazil
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Computer S.A. (Spain)
Secondary
Madrid
Spain
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Computer Services de Mexico,
Secondary
Jalisco
Mexico
ISO 9001:2008
The provision of infrastructure ITO services at the Guadalajara Service Center
Dell Computer spol. s.r.o.
Secondary
Prague
Czech Republic
ISO 9001:2008
All Provisions of Customer Service and Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Computers S.A. (South Africa)
Secondary
Johannesburg
South Africa
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Corporation (Thailand) Co., Ltd.
Secondary
Bangkok
Thailand
ISO 9001:2008
All Provisions of Customer Service and Support for Computers, Technology Products and
Solutions
Dell Corporation Ltd
Secondary
Nottingham
United Kingdom
ISO 9001:2008
The provision of infrastructure ITO services in the United Kingdom
COMPANY
Dell Cloud Clinical Archive (DCCA)
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The Manufacture and Supply of Computers and Technology Products.
4/10/2015
Profile
Type
CITY
Dell Corporation Ltd
Secondary
Dell Corporation Ltd
COMPANY
Country
Scheme
Bracknell, Berkshire
United Kingdom
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Secondary
London
United Kingdom
ISO 9001:2008
The Provision of Project Management, IT Consultancy, Systems Integration, Software
Deployment and Support by the Healthcare Group of Dell Services, Europe.
Dell Corporation Ltd.
Secondary
Glasgow
United Kingdom
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Force 10
Secondary
San Jose
CA
USA
ISO 9001:2008
The design, development and supporting functions for networking products and services.
Dell Force 10
Secondary
Petaluma
CA
USA
ISO 9001:2008
The design, development and supporting functions for networking products and services.
Dell Global B.V. (Singapore Branch)
Secondary
Singapore
Singapore
ISO 9001:2008
The Design, Development, Product Line Marketing, provision of Customer Service, Support
and Sales Operations for Computers, Technology Products and Solutions.
Dell GmbH
Secondary
60549 Frankfurt am
Main
Germany
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Halle GmbH
Secondary
Halle (Saale)
Germany
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Tokyo
Japan
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for
Computers, Technology Products and Solutions.
Dell Inc.
Secondary
Selangor Darul Ehsan
Malaysia
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Bagumbayan, Quezon
City
Philippines
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Penang
Malaysia
ISO 9001:2008
Regional call centre for sales operations and maintain sales, customer service and technical
support. Regional administrative centre for marketing, finance and information technology
services. Global IT supports and global procurement.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 14001:2004
Global product development
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 14001:2004
Global Takeback (Asset Resale and Recycling Services & Producer Responsibility).
Dell Inc.
Primary
Round Rock
TX
USA
ISO 9001:2008
The Design, Development, Manufacture, Procurement, Fulfillment, Delivery, Sales
Operations, Customer Service, Take-Back & Recycling, Refurbishment and Supporting
Functions of Computers, Technology Products, Services and Solutions
Dell Inc.
Secondary
Nashville
TN
USA
ISO 9001:2008
The Fulfillment & Delivery, Sales Operations, Customer Service, and Supporting Functions of
Computers and Technology Products and Services
Dell Inc.
Secondary
Dublin
Ireland
ISO 9001:2008
The Design, Development and Services and Solutions and Provisions of Customer Service,
Support, Sales Operations and Customer Care for Computers, Technology Products and
Solutions
Dell Inc.
Secondary
Kanagawa
Japan
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Miyazaki
Japan
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Shanghai
China
ISO 9001:2008
Sales, Sales Operations, Customer Service and Supporting Functions of Computers and
Technology Products and Services.
Dell Inc.
Secondary
Saint Denis (Paris)
France
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Mexico City
Mexico
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Panama City
Panama
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Inc.
Secondary
Round Rock
USA
ISO 9001:2008
The Design, Development, Manufacture, Delivery, Sales Operations, Fulfillment, Customer
Service, and Supporting Functions of Computers and Technology Products, Services and
Solutions
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
TX
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 9001:2008
All Provisions of Sales Operations and Customer Care for Computers, Technology Products
and Solutions for Federal Systems.
Dell Inc. (Compellent)
Secondary
Eden Prairie
MN
USA
ISO 9001:2008
The Design, Development, Sales Operations, Support, Services and Customer Care for
Computers, Technology Products and Solutions.
Dell Inc. (Compellent)
Secondary
Eden Prairie
MN
USA
ISO 9001:2008
The Design, Development, Sales Operations, Support, Services and Customer Care for
Computers, Technology Products and Solutions.
Dell Inc. (Copilot)
Secondary
Edina
MN
USA
ISO 9001:2008
The Design, Development, Sales Operations, Support, Services and Customer Care for
Computers, Technology Products and Solutions.
Dell Inc. (KACE)
Secondary
Mountain View
CA
USA
ISO 9001:2008
The Design, Development and Supporting Functions for Deployment and Systems
Management Appliances
Dell International Inc. (Korea)
Secondary
Seoul
Korea
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell International Services India
Secondary
Tamilnadu
India
ISO 9001:2008
Manufacture, Fulfilment & Delivery of Computers and Technology products requested by Dell
sales centres for shipping to customers
Dell International Services India
Secondary
Kancheepuram,
Tamilnadu
India
ISO 14001:2004
Manufacture of Computers and Technology Products
Dell International Services India Pvt.
Secondary
Bangalore
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions. Central Management Group for Consumer,
Small & Medium Business Services
Dell International Services India Pvt.Lt
Secondary
India
ISO 9001:2008
The Design, Development and Supporting Functions Of Computers And Technology Products
And Services.
Dell International Services India,
Secondary
Uttar Pradesh
India
ISO 9001:2008
The provision of infrastructure ITO services at the Noida Service Center.
Dell International Services India,
Secondary
Karnataka
India
ISO 9001:2008
The provision of infrastructure ITO services at the Bangalore Service Center.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
Dell International Services India,
Secondary
Dell International Services India,
COMPANY
STATE
Country
Scheme
Scope
Punjab
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Secondary
Andhra Pradesh
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales and Customer Care for Computers,
Technology Products and Solutions
Dell International Services India,
Secondary
Haryana
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell International Services S.R.L.
Secondary
Bucharest
Romania
ISO 9001:2008
The provision of infrastructure ITO services at the Bucharest Service Center
Dell Italian Services
Secondary
6 Milano
Italy
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and SolutionsIncorporates the Full Range of Dell Services,
including: Systems and Applications Managment, Maintenance and Development; Technical
and Business Consulting; Technical Assistance, Support, Service Desk and Call Center
ManagmentProduct Support; Education and End User Support
Dell Limerick
Secondary
Limerick
Ireland
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Marketing L.P.
Secondary
Lincoln
USA
ISO 9001:2008
The provision of infrastructure information technology outsourcing services at the Lincoln
Service Center.
Dell Marketing L.P.
Secondary
Chennai, Tamil Nadu
India
ISO 9001:2008
The provision of infrastructure ITO services at the Chennai Service Center.
Dell Mobility Products
Primary
Dell Mobility Products
Secondary
Dell N.V.
Secondary
Dell New Zealand Limited
Secondary
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Round Rock
Santa Clara
Auckland
NE
TX
CA
TL 9000 R5.0/5.0
TL 9000-HSV Scope: The design, development and customer support service of complex
wireless subscriber user terminals (Product Category 6.2.1.2.2 Complex Wireless Subscriber
User Terminals)9K Scope: The design, development and customer support service of
complex wireless subscriber user terminals
USA
TL 9000 R5.0/5.0
TL 9000-HSV Scope: The design, development and customer support service of complex
wireless subscriber user terminals (Product Category 6.2.1.2.2 Complex Wireless Subscriber
User Terminals)9K Scope: The design, development and customer support service of
complex wireless subscriber user terminals
Belgium
ISO 9001:2008
All Provisions of Customer Service and Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions.
New Zealand
ISO 9001:2008
Sales, Sales Operations, Customer Service and Support for a range of desktop, server and
notebook computers and associated peripherals.
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
DELL Products (Poland) Sp. z o.o.
Secondary
Dell Products (Poland) Sp. z o.o.
Secondary
Dell Products (Poland) Sp. z o.o.
Secondary
Dell S.A (Greece)
Secondary
Dell S.A. (France)
COMPANY
Country
Scheme
92-410 Lodz
Poland
ISO 9001:2008
The manufacture and supply of computer and related products and solutions in EMFP
(European Manufacturing Facilty Poland)
Lodz
Poland
ISO 14001:2004
The manufacture and supply of computer and related products and solutions.
Poland
OHSAS 18001:2007
The manufacture and supply of computer and related products and solutions.
Athens
Greece
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Secondary
Montpellier - 34000
France
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell s.r.o
Secondary
Bratislava
Slovak Republic
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions.Includes General Procurement and Finance
Functions.
Dell SA
Secondary
1215 Genève 15
Switzerland
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell SAS
Secondary
20270 Casablanca
Morocco
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell Services - Insurance Services
Secondary
Lincoln
NE
USA
ISO 9001:2008
Dell Insurance Services provides back office policy administration, new business issue, call
center support and ancillary services on behalf insurance company clients as well as provide
customer application enhancement programs and projects.
Dell Services - Insurance Services
Secondary
Omaha
NE
USA
ISO 9001:2008
Dell Insurance Services provides back office policy administration, new business issue, call
center support and ancillary services on behalf insurance company clients as well as provide
customer application enhancement programs and projects.
Dell Technology & Solutions Israel Ltd
Secondary
Herzliya Pituach
Israel
ISO 9001:2008
The Design and Development of Storage Systems and Solutions
Single
Santa Clara
USA
ISO 14001:2004
Product Development
Dell Wyse
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
CA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Dell, Inc.
Secondary
Oklahoma City
OK
USA
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for
Computers, Technology Products and Solutions
Dell, Inc.
Secondary
Costa Rica S.A.
ISO 9001:2008
Technical Support
Dell, Inc.
Secondary
Nashua
NH
USA
ISO 9001:2008
Research, Design and Development of Storage Systems and Supporting Functions.
Dell, Inc.
Secondary
Atlanta
GA
USA
ISO 9001:2008
Providers of IT Managed Security and Consultancy Services
Dell, Inc.
Secondary
Providence
RI
USA
ISO 9001:2008
Providers of IT Managed Security and Consultancy Services
Dell, Inc.
Primary
Round Rock
TX
USA
ISO 14001:2004
The Development, Manufacture, Supply, and Takeback Services of Computers and
Technology Products.
Dell, Inc.
Primary
Round Rock
TX
USA
OHSAS 18001:2007
Device Technologies, Inc.
Single
Southborough
MA
USA
AS 9100 - C
Designs, Develops, Manufactures and Distributes Electronic and Environmental Wire
Protection, Enclosure Sealing, Cable Management Materials and Specialty Fastener Products
and Assemblies, and Linear Polymer Dielectric Coating Services.
DEX Corporation Northeast
Single
Groveport
OH
USA
ISO 9001:2008
A Provider of Product Returns, Testing and Repair Solutions for a Wide Variety of Customers
and Industries.
diaDexus, Inc.
Single
South San Francisco
CA
USA
EN ISO 13485:2012
Design, manufacture and distribution of In-Vitro diagnostic reagents for the determination and
evaluation of cardiovascular biomarkers.
Direct Flow Medical, Inc.
Secondary
Santa Rosa
CA
USA
ISO 13485/CMDCAS
Design, manufacture, and distribution of percutaneous aortic heart valves and delivery
systems.
Direct Flow Medical, Inc.
Secondary
Lake Forest
CA
USA
ISO 13485/CMDCAS
Design, manufacture, and distribution of percutaneous aortic heart valves and delivery
systems.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Manufacture and Supply of Computers and Technology Products
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
Santa Rosa
CA
USA
ISO 13485/CMDCAS
Dolphin Press
Single
South San Francisco
CA
USA
ISO 9001:2008
DONGGUAN MEADVILLE CIRCUITS LIMITED
Single
Guangdong
China
ECCB HSPM
Manufacture of double-sided and multilayer printed circuit boards.
Dongguan WKK Electronics Co. LTD.
Single
Guangdong Province,
China
AS 9100 - C
The Manufacture of Relay Panel Printed Circuit Board Assemblies. Exclusions: Product
Design and Development and Post Delivery support (Service Operations)
Dow Corning Alabama, Inc.
Single
Mt. Meigs
AL
USA
ISO 9001:2008
The Manufacture of Silicon Metal, Chemical Grade: Primary Aluminum Grade and Secondary
Aluminum Grade.
DRA Component Services Inc.
Single
Methuen
MA
USA
ISO 9001:2008
The provision of device programming, tape and reeling, parametric and functional testing and
environmental screening of electronic components.
COMPANY
Direct Flow Medical, Inc.
Scope
Design, manufacture, and distribution of percutaneous aortic heart valves and delivery
systems.
Manufacture of Labels for Packaging Industry
DRS Power Technology, Inc.
Single
Fitchburg
MA
USA
AS 9100 - C
AS9100C Scope: Design, Engineering and Manufacturing of Gas Turbine Packaging, Steam
Turbine and Permanent Magnet Electric Motors and Generators for Naval, Marine, Military
Vehicles, Oil, Gas and Power Generator Applications.ISO 9001:2008 Scope: Design,
Engineering and Manufacturing of Gas Turbine Packaging, Steam Turbine and Permanent
magnet Electric Motors and Generators for Naval, Marine, Military Vehicles, Oil, Gas and
Power Generation Applications.
DRT Medical LLC
Single
Dayton
OH
USA
EN ISO 13485:2012
Precision Manufacturing of Medical Implants, Medical Instruments, Medical Components and
Devices for the Orthopedic Industry.
Duke Energy Renewable Service
Single
Canby
MN
USA
ISO 14001:2004
The provision of technical services, including project operations and maintenance activities to
the North American wind industry.
Duke Energy Renewable Service
Single
Canby
MN
USA
ISO 9001:2008
The provision of technical services, including project operations and maintenance activities to
the North American wind industry.
Duke Energy Renewable Service
Single
Canby
MN
USA
OHSAS 18001:2007
The provision of technical services, including project operations and maintenance activities to
the North American wind industry.
Dunn Industries, Inc.
Single
Manchester
NH
USA
ISO 9001:2008
The custom extrusion of precision small diameter thermoplastic tubing for the medical device
industry and other exacting commercial applications.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Eagle Stainless & Tube Fabrication, Inc
Secondary
Franklin
MA
USA
EN ISO 13485:2012
Distribution, fabrication and assembly of metal and plastic components for the medical device
industry.
Eagle Stainless Tube & Fabrication, Inc.
Secondary
Franklin
MA
USA
AS 9100 - C
The distribution, fabrication and assembly of Stainless Steel components and other metals
such as Aluminum, Titanium and Copper.Site Specific Activity: Warehouse
Eagle Stainless Tube & Fabrication, Inc.
Primary
Franklin
MA
USA
AS 9100 - C
The distribution, fabrication and assembly of Stainless Steel components and other metals
such as Aluminum, Titanium and Copper.
Eagle Stainless Tube & Fabrication, Inc.
Primary
Franklin
MA
USA
EN ISO 13485:2012
Distribution, fabrication and assembly of metal and plastic components for the medical device
industry.
East Coast Microwave
Single
Woburn
MA
USA
AS 9100 - C
Distribution and assembly of RF Microwave components, connectors, and cable assemblies.
Eaton B-Line Business - Wright Line
Single
Worcester
MA
USA
ISO 9001:2008
Design, Manufacture, Distribute, Install and Service Consoles and Enclosures for Data
Centers, Control Rooms, Network Operations Centers, 911 Dispatch Centers, and
Professional Office Settings.
Primary
Raleigh
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and
systems for the computer and telecommunications markets.
Eaton Power Quality Operations
Secondary
Youngsville
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and
systems for the computer and telecommunications markets.
Eaton Power Quality Operations
Secondary
Raleigh
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and
systems for the computer and telecommunications markets.
Eaton Power Quality Operations
Secondary
Raleigh
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and
systems for the computer and telecommunications markets.
eBioscience, Inc.
Secondary
San Diego
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Immunological Reagents, Including Antibodies
and Reagents for Flow Cytometry in the Fields of Immunology and Oncology.
eBioscience, Inc.
Primary
San Diego
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Immunological Reagents, Including Antibodies
and Reagents for Flow Cytometry in the Fields of Immunology and Oncology.
COMPANY
Eaton Corporation
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
EDO Western Corporation
Single
Salt Lake City
UT
USA
ISO 9001:2008
The design and manufacture of piezoelectric ceramic for the military, medical, automotive,
geophysical and ultrasonic industries. Transducer and hydrophone array design and
manufacture for military and commercial applications.
Electronic Components, Inc.
Single
Framingham
MA
USA
AS 9120:2009
THE SOURCING, COUNTERFEIT MITIGATION AND DISTRIBUTION OF ELECTRONIC AND
ELECTRO-MECHANICAL PRODUCTS.
Emhart Glass Manufacturing Inc.
Single
Elmira
NY
USA
ISO 9001:2008
The Manufacture of Capital Equipment Used for the Inspection and Handling of Glass
Containers.
Emhart Glass Manufacturing Inc.
Single
Owensville
MO
USA
ISO 9001:2008
The Manufacture of Capital Equipment and Parts used in the Manufacture of Glass Products
and Containers to Control and Equalize the Temperature of Molten Glass.
Endologix, Inc
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and
Peripheral Catheters.
Endologix, Inc.
Primary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and
Peripheral Catheters.
Endologix, Inc.
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and
Peripheral Catheters.
Endologix, Inc.
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and
Peripheral Catheters.
Endologix, Inc.
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and
Peripheral Catheters.
EnerSys
Single
Cleveland
OH
USA
ISO 9001:2008
The design and manufacture of battery charging systems.
EnerSys
Primary
Richmond
KY
USA
ISO 9001:2008
Manufacturing and distribution of lead acid batteries and associated parts.
EnerSys
Single
Hays
KS
USA
ISO 9001:2008
The manufacture of lead acid batteries and accessories.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
EnerSys
Single
Hays
KS
USA
ISO 14001:2004
The manufacture of lead acid batteries and accessories.
EnerSys
Single
Tijuana B.C.
Mexico
ISO 9001:2008
The manufacture of sealed lead acid batteries.
EnerSys
Single
Reading
USA
TL 9000 R5.0/5.0
EnerSys
Primary
Newport, Gwent Wales
United Kingdom
ISO 9001:2008
The design and manufacture of sealed lead acid batteries
EnerSys
Primary
Gwent
United Kingdom
ISO 14001:2004
The design and manufacture of sealed lead acid batteries.
EnerSys
Secondary
Newport
United Kingdom
ISO 9001:2008
The design and manufacture of sealed lead acid batteries
EnerSys
Secondary
Newport
United Kingdom
ISO 14001:2004
The design and manufacture of sealed lead acid batteries
EnerSys
Secondary
Richmond
KY
USA
ISO 9001:2008
Manufacturing and distribution of lead acid batteries and associated parts.
EnerSys
Secondary
Richmond
KY
USA
ISO 9001:2008
Manufacturing and distribution of lead acid batteries and associated parts.
Single
Horsham
PA
USA
ISO 9001:2008
The design, development and manufacture of lithium ambient temperature, lithium thermal
and lithium ion battery products for the defense industry.
ENERSYS DE MEXICO II, S. DE R.L. DE C.V.
Secondary
N.L. Mexico
Mexico
ISO 9001:2008
The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays.
ENERSYS DE MEXICO S. DE R.L. DE C.V.
Secondary
Apodaca, N.L.
Mexico
ISO 9001:2008
The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays.
COMPANY
EnerSys Advanced Systems
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
PA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
TL9000-H Scope: The design and manufacture of Reserve Power Products FTA, FTC, GC,
GU, SBS, VF and M Series batteries installed in telecom applications for specific telecom
customers, in the following reporting categories: 5.3 Power Systems.ISO 9001:2008 Scope:
The design, manufacture and service of batteries, chargers and accessories.
4/10/2015
Profile
Type
CITY
Primary
N.L.
EnerSys Delaware Inc.
Single
Sumter
EnerSys Energy Products
Single
EnerSys Energy Products, Inc.
COMPANY
Country
Scheme
Mexico
ISO 9001:2008
The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays.
SC
USA
ISO 9001:2008
The Manufacture of Steel Trays.
Warrensburg
MO
USA
ISO 9001:2008
The design and manufacture of lead acid batteries.
Single
Warrensburg
MO
USA
ISO 14001:2004
The design and manufacture of lead acid batteries
EnerSys S.A.R.L.
Single
Cedex
France
ISO 9001:2008
Design, Development, Production, Sales and Servicing of Lead Acid Technology Industrial
Batteries and power chargers.
EnerSys S.A.R.L.
Single
Cedex
France
ISO 14001:2004
Manufacturing of lead acid technology industrial batteries and (battery) chargers.Fabrication
de batteries Industrielles de Technologie Plomb/Acide et de chargeurs.
EnerSys S.r.l.
Single
Gambellara (VI)
Italy
ISO 9001:2008
Manufacture, sale and installation of traction, stationary, special use batteries and
accessories.
EnerSys S.R.O.
Single
Czech Republic
ISO 14001:2004
Design, Development, Production, Sales and Service of Industrial and ATEX Batteries and
their Accessories. Sales and Service of Reserve Power Supplies. Production of Trays for
Industrial Batteries.
EnerSys s.r.o.
Secondary
Slovenská republika
ISO 9001:2008
Production, sales and service of industrial batteries and their accessories. Sales and service
of reserve power supplies. Production of trays for industrial batteries
EnerSys s.r.o.
Secondary
Ceská republika
ISO 9001:2008
Production, sales and service of industrial batteries and their accessories. Sales and service
of reserve power supplies. Production of trays for industrial batteries
EnerSys s.r.o.
Primary
Czech republika
ISO 9001:2008
Production, sales and service of industrial batteries and their accessories. Sales and service
of reserve power supplies. Production of trays for industrial batteriesOsvedcení o registraci
EnerSys s.r.o.
Single
Czech Republic
ISO 14001:2004
Design, Development, Production, Sales and Service of Industrial and ATEX Batteries and
their Accessories. Sales and Service of Reserve Power Supplies. Production of Trays for
Industrial Batteries.
ENERSYS DE MEXICO S. DE R.L. DE C.V.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
EnerSys Sp. z o.o.
Single
EnerSys Sp. z o.o.
COMPANY
Country
Scheme
43-300 Bielsko-Biala
Poland
ISO 9001:2008
Design, Development, Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and
Components.
Single
43-300 Bielsko-Biala
Poland
ISO 14001:2004
Design, Development, Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and
Components.
EnerSys Sp. z o.o.
Single
43-300 Bielsko-Biala
Poland
OHSAS 18001:2007
Design, Development, Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and
Components.
Environmental Reclamation Services, LLC
Single
Erie
PA
USA
ISO 14001:2004
Inspection and sale of used laser and inkjet printer cartridges, cellphones and consumer
electronic products.
EORM, Inc
Primary
San Jose
CA
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc
Secondary
Laguna Hills
CA
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc
Secondary
Alameda
CA
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc
Secondary
Hillsboro
OR
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc.
Secondary
Oxnard
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc.
Secondary
Oxnard
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc.
Primary
San Jose
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc.
Secondary
Laguna Hills
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
EORM, Inc.
Secondary
Alameda
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
EORM, Inc.
Secondary
Hillsboro
OR
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems
Consulting Services.
COMPANY
Epic Medical Concepts & Innovations
Secondary
Grain Valley
MO
USA
Scope
EN ISO 13485:2012
13485 Scope: Contract and proprietary design and development, manufacturing, distribution
and servicing of active medical systems for neurological diagnostics, active and non-active
surgical instruments and suction catheters for plastic, orthopedic,thoracic and general
surgery. 9k Scope:Design, development, manufacturing, distribution and servicing of active
and non-active diagnostic and therapeutic medical devices and surgical instruments for
plastic, orthopedic and general surgery; Metalfinishing and engraving services for Industrial
and Medical applications.
Primary
Mission
KS
USA
EN ISO 13485:2012
13485 Scope: Contract and proprietary design and development, manufacturing, distribution
and servicing of active medical systems for neurological diagnostics, active and non-active
surgical instruments and suction catheters for plastic, orthopedic,thoracic and general
surgery. 9k Scope:Design, development, manufacturing, distribution and servicing of active
and non-active diagnostic and therapeutic medical devices and surgical instruments for
plastic, orthopedic and general surgery; Metalfinishing and engraving services for Industrial
and Medical applications.
ErgoMet Inc
Single
Ward Hill
MA
USA
ISO 9001:2008
Manufacturing of Precision Sheet Metal parts and assemblies for diverse industries, including
medical.
Excelitas Canada Inc.
Single
Quebec
Canada
OHSAS 18001:2007
Design, manufacturing and test of optoelectronic devices.
Excelitas Canada Inc.
Single
Quebec
Canada
ISO 9001:2008
Design, manufacturing and test of optoelectronic devices.
Excelitas Canada Inc.
Single
Quebec
Canada
ISO 14001:2004
The Design, Manufacturing and Test of Optoelectronic Devices.
Excelitas Technologies (Shenzhen)
Single
Shenzhen
China
ISO 9001:2008
Design and Manufacture of Flash Lamps, Photocells and Solid State Lighting Products.
Excelitas Technologies (Shenzhen)
Single
Shenzhen
China
ISO 14001:2004
Design and Manufacture of Flash Lamps, Photocells and Solid State Lighting Products.
Excelitas Technologies (Shenzhen)
Single
Shenzhen
China
OHSAS 18001:2007
Design and Manufacture of Flash Lamps, Photocells and Solid State Lighting Products.
Epic Medical Concepts & Innovations
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Excelitas Technologies Corp.
Single
Salem
MA
USA
ISO 14001:2004
The design and manufacture of electro-optical components, high energy switches, medical
component, time frequency standards, high voltage power conversion systems and X-ray
sources.
Excelitas Technologies Corp.
Single
Covina
CA
USA
AS 9100 - C
The design, manufacture and servicing of power supplies, power conditioning devices and
optoelectronic systems.
Excelitas Technologies Corp.
Single
Salem
MA
USA
OHSAS 18001:2007
The design and manufacture of electro-optical components, high energy switches, medical
component, time frequency standards, high voltage power conversion systems and X-ray
sources.
Excelitas Technologies Corp.
Single
Miamisburg
OH
USA
OHSAS 18001:2007
Design and manufacture of electro-optic components, energetic devices and electronic safe
and arm devices.
Excelitas Technologies Corporation
Single
Salem
MA
USA
ISO 9001:2008
The design and manufacture of electro-optical components, high energy switches, medical
component, time frequency standards, high voltage power conversion systems and X-ray
sources.
COMPANY
Scope
Excelitas Technologies Corporation
Single
Fremont
CA
USA
EN ISO 13485:2012
ISO 13485 Scope: Design, development, manufacture and distribution of electrical lamps,
lamp modules, optical equipment and power supplies including system integration and testing
for the medical device industry.ISO 9001 Scope: Design, development, manufacture and
distribution of specialty lamps, lighting equipment, optical equipment and power supplies for
the medical, industrial, communication, aerospace, scientific, entertainment and military
markets.
Excelitas Technologies Corporation
Single
Covina
CA
USA
OHSAS 18001:2007
The design, manufacture and servicing of power supplies, power conditioning devices, and
optoelectronic systems
Excelitas Technologies Corporation
Single
Covina
CA
USA
ISO 14001:2004
The design, manufacture and servicing of power supplies, power conditioning devices and
optoelectronic systems.
Excelitas Technologies Elcos GmbH
Single
85622 Feldkirchen
Germany
ISO 9001:2008
Development, manufacturing and distribution of optoelectronics components.
Excelitas Technologies Elcos GmbH
Single
85622 Feldkirchen
Germany
OHSAS 18001:2007
Excelitas Technologies GmbH & Co.KG
Single
Wiesbaden
Germany
ISO 9001:2008
Design and Distribution of Optoelectronic Products.
Excelitas Technologies GmbH & Co.KG
Single
Wiesbaden
Germany
OHSAS 18001:2007
Design and Distribution of Optoelectronic Products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Development, manufacturing and sales of optoelectronic components.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Excelitas Technologies Inc.
Single
Fremont
CA
USA
ISO 14001:2004
Design, Development, Manufacture and Distribution of Specialty Lamps and Lighting
Equipment for the Medical, Industrial, Communication, Aerospace, Scientific, Entertainment
and Military Markets.
Excelitas Technologies Inc.
Secondary
Fremont
CA
USA
OHSAS 18001:2007
Design, Development, Manufacture and Distribution of Specialty Lamps and Lighting
Equipment for the Medical, Industrial, Communication, Aerospace, Scientific, Entertainment
and Military Markets.
Excelitas Technologies Inc.
Single
Wheeling
IL
USA
EN ISO 13485:2012
MD Scope: The design, manufacture and contract development of LED electrical lamps and
lamp modules for the medical device industry.ISO9K Scope: Design and manufacture of LED
based lighting solutions
Excelitas Technologies Philippines, Inc.
Single
Laguna
Philippines
ISO 14001:2004
Manufacture and Test of Optoelectronic Components and Assemblies.
Excelitas Technologies Philippines, Inc.
Single
Laguna
Philippines
OHSAS 18001:2007
Manufacture and Test of Optoelectronic Components and Assemblies.
Excelitas Technologies Philippines, Inc.
Single
Laguna
Philippines
ISO 9001:2008
Manufacture and Test of Optoelectronic Components and Assemblies.
Excelitas Technologies Sensors, Inc.
Single
Miamisburg
USA
ISO 9001:2008
Design and Manufacturing of Energetic Components used for DOD, DOE and commercial
applications.
Singapore
ISO 9001:2008
Design and Manufacture of Optoelectronics Products
The Design, Development and Manufacture of Chemicals, Polymers, and Pharmaceutical
Intermediates.
COMPANY
Excelitas Technologies Singapore Pte Ltd
OH
Secondary
Far Research Inc.
Single
Palm Bay
FL
USA
ISO 9001:2008
FastForm Research Ltd
Single
Killowen
Co.
Waterford
Ireland
EN ISO 13485:2012
Fiberoptic Components, LLC
Single
Sterling
Filtertek
Single
Co. Limerick
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
USA
ISO 13485:2003
Ireland
EN ISO 13485:2012
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The design and development, manufacture, and distribution of medical devices for
orthopaedic and soft-tissue splinting and support.
ISO 13485:2003 Scope: The Design and Manufacture of Fiber Optic Cable, Components and
Sub Assemblies for the Medical Device Industry.ISO 9001:2008 Scope: The Design and
Manufacture of Fiber Optic Cable, Components and Sub Assemblies for the Commercial and
Medical Device Industry.
ISO 13485 Scope: The design, manufacture and packaging of sterile and non-sterile plastic
moulded products, filters and valves for the medical device industry.ISO 9001 Scope: The
design and manufacture of specialised plastic moulded products, filters and valves for the
commercial, automotive and industrial markets.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
First State Mfg.
Single
Milford
DE
USA
AS 9100 - C
Flextronics International Cork B.V.
Single
Fluidmaster Water Technology
Single
Guadalupe, N.L.
Fluidmaster, Inc.
Single
San Juan Capistrano
FMC Health & Nutrition
Single
Foam Pack/Future Pack
Focal Therapeutics
COMPANY
Cork
I.S. EN ISO 13485:2003
Scope
AS9100: Manufacture of Custom Sewn & Upholstered products for the Aerospace Industry.
The manufacture of printed circuit board assemblies (PCBA's) for non-invasive medical
products.
Mexico
ISO 9001:2008
The manufacture and assembler of toilet trim and proprietary plumbing products.
CA
USA
ISO 9001:2008
The design, pilot production, sales and supply chain management of toilet trim and proprietary
plumbing products.
Newark
DE
USA
ISO 9001:2008
The Manufacture of Excipients for the Food and Pharmaceutical Industries, and Natural Color
Additives for the Food Industry.
Single
San Juan
PR
Puerto Rico
ISO 9001:2008
The manufacture of corrugated and foam packaging.
Single
Portola Valley
CA
USA
EN ISO 13485:2012
Secondary
Chennai, Tamil Nadu
600 032
India
ISO 9001:2008
Foresight Imaging, LLC
Single
Chelmsford
MA
USA
EN ISO 13485:2012
Freedom USA, Inc.
Single
Twinsburg
OH
USA
ISO 9001:2008
Force 10 Networks India Pvt. Ltd.
Fugang Electric (Kunshan) Co., Ltd.
Single
Jiang Su Province
G&F Medical, Inc.
Single
Danvers
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
China
TL 9000 R5.0/5.0
USA
EN ISO 13485:2012
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design, manufacture and distribution of bioabsorbable radiopaque tissue markers, and
associated accessories.
The design, development and supporting functions for networking products and services.
ISO 13485: The design, manufacture, sales and service of video imaging boards, systems
and software for medical markets.ISO 9001: The design, manufacture, sales and service of
video imaging boards, systems and software for medical and industrial markets.
Internet processing of custom hardware and software solutions, assembly, repair and
consulting services for one stop shop end users.
TL9000-H Scope: Manufacture and Sales of Communication Products and Semi-Products
such as Mobile Phone, Blue Tooth, PND (Personal Navigation Device) Accessoriesfor the
Following Product Category: 7.7.4 Electromechanical AssemblyISO9K Scope: Manufacture
and Sales of Communication Products and Semi-Products such as Mobile Phone, Blue Tooth,
PND (Personal Navigation Device) Accessories
MD Scope: The Manufacture of Injection Molded Components for the Medical Device
Industry.ISO9K Scope: The Manufacture of Injection Molded Parts.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
Chicago
IL
USA
ISO 9001:2008
Garmin AT
Secondary
Salem
OR
USA
AS 9100 - C
Garmin AT
Secondary
Salem
OR
USA
ISO 9001:2008
Garmin International
Secondary
New Century
KS
USA
AS 9100 - C
Garmin International
Secondary
Olathe
KS
USA
ISO 9001:2008
Call Center in support of navigation, communication, and information devices with applications
for aerospace, marine, outdoor recreation, automotive, wireless and OEM markets
Garmin International
Secondary
Kansas City
MO
USA
ISO 9001:2008
Call Center in support of navigation, communication, and information devices with applications
for aerospace, marine, outdoor recreation, automotive, wireless and OEM markets
Garmin International
Secondary
Salem
OR
USA
ISO 9001:2008
Design, manufacture, distribution and support of navigation, communication and information
devices with applications for aerospace, marine, outdoor recreation, automotive, wireless and
OEM markets.
Garmin International
Primary
Olathe
KS
USA
ISO 9001:2008
Design, manufacture, distribution, and support of navigation, communication, and information
devices with applications for aerospace, marine, outdoor recreation, automotive, wireless and
OEM markets.
AS9100 Scope: Design, Manufacture, Certification, Distribution, and Support of Navigation,
Communication, and Flight Control Equipment for Aerospace Applications.ISO 9001:2008
Scope: Design, manufacture, distribution, and support of navigation, communication and
information devices with applications for aerospace, marine, outdoor recreation, automotive,
wireless and OEM markets
COMPANY
G.E. Mathis Company
Scope
Manufacture of general steel fabrications and assemblies for, but not limited to, industries
such as; agricultural equipment, chemical container, construction equipment, energy and
mining.
Design, Manufacture, Certification, Distribution, and Support of Navigation, Communication,
and Flight Control Equipment for Aerospace Applications.
Design, manufacture, distribution and support of navigation, communication and information
devices with applications for aerospace, marine, outdoor recreation, automotive, wireless and
OEM markets.
Flight Operations center performing Design and Certification activities in support of
Navigation, Communication, and Flight Control Equipment for Aerospace Applications
Garmin International
Primary
Olathe
KS
USA
AS 9100 - C
Garmin International
Primary
Olathe
KS
USA
ISO 14001:2004
Design, Manufacture, Distribution and Support of Navigation, Communication, and Information
Devices with Applications for Aerospace, Marine, Outdoor Recreation, Automotive, Wireless
and OEM Markets.
Garmin International
Secondary
New Century
KS
USA
ISO 14001:2004
Design, Manufacture, Distribution and Support of Navigation, Communication, and Information
Devices with Applications for Aerospace, Marine, Outdoor Recreation, Automotive, Wireless
and OEM Markets.
GatesAir
Secondary
Quincy
IL
USA
ISO 9001:2008
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products
for use in Broadcast Communications and related media industries.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
GatesAir
Primary
Mason
OH
USA
ISO 9001:2008
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products
for use in Broadcast Communications and related media industries.
GatesAir
Single
Quincy
IL
USA
OHSAS 18001:2007
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products
for use in Broadcast Communications and related media industries.
GatesAir
Single
Quincy
IL
USA
ISO 14001:2004
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products
for use in Broadcast Communications and related media industries.
Secondary
D-08056 Zwickau
Germany
ISO 9001:2008
Development, production and sales of industrial batteries and aircraft NiCd batteries and
accessories.
Gemini Technical Services, Inc.
Single
Bow
NH
USA
ISO 9001:2008
Repair of Printed Circuit Boards and Associated Assemblies
General Dynamics Global Imaging Tech.
Single
Cullman
AL
USA
AS 9100 - C
COMPANY
GAZ GmbH
Geneva Laboratories
Single
Elkhorn
WI
USA
IECQ ITL
Scope
The Ultra-Precision Machining of Beryllium, Conventional and other Exotic Materials and the
Design, Development, Production and Assembly of Optical Components such as Lenses,
Filters, Mirrors and Telescopes.
Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing
applicable International and U.S. standards for a variety of medical device, supplies,
laboratory and diagnostic products. Chemical and electrical testing of electronic components
and assemblies used in instruments. Tests include: Gram Stain, Ames Test, Hemolysis Test,
Cytotoxicity Assay, Antimicrobial Effectiveness Test, Microbial Limits, Bacterial Endotoxin,
Particle Count, Package Integrity, Sterility, Bioburden, Physico-chemical Test, Intracutaneous
Test, Acute Systemic Toxicity Test, Ocular Irritation Test, Penile Mucosa Irritation Test,
Closed Patch Sensitization, Dermal Sensitization, Intramuscular Implantation Test, Oral
Mucosa Irritation, Vaginal Mucosa Irritation, Primary Skin Irritation, and Muscle Implantation
Test.
Geneva Laboratories
Single
Elkhorn
WI
USA
ISO 9001:2008
Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing
applicable International and U.S. standards for a variety of medical device, supplies,
laboratory and diagnostic products. Chemical and electricaltesting of electronic components
and assemblies used in instruments.
GIT Satellite LLC
Single
Austin
TX
USA
ISO 14001:2004
Provider of Satellite Communication Products and Services. Design, Development and
Manufacturing of Satellite Communications Equipment.
GIT Satellite LLC
Single
Austin
TX
USA
ISO 9001:2008
Provider of Satellite Communication Products and Services. Design, Development and
Manufacturing of Satellite Communications Equipment.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Global Instrumentation LLC
Single
Manlius
NY
USA
ISO 13485/CMDCAS
Globaltek Components LLC
Single
Milton
NH
USA
ISO 9001:2008
GRAFTYS
Secondary
Cedex 3
France
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone
Void Fillers and related Delivery Systems.
GRAFTYS
Secondary
Cedex 3
France
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone
Void Fillers and related Delivery Systems.
GRAFTYS
Primary
Cedex 3
France
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone
Void Fillers and related Delivery Systems.
Greatbatch Medical
Secondary
Fort Wayne
IN
USA
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants,
instruments and sterilization cases, trays and lids. (Corporate Headquarters, and the Sales,
Marketing, and Customer Service area for commercial business)
Greatbatch Medical
Secondary
Indianapolis
IN
USA
ISO 13485/CMDCAS
Design, develoment, manufacturing, and distribution of orthopaedics and trauma implants,
instruments and sterilization cases, trays and lids. (Corporate Headquarters, and the Sales,
Marketing, and Customer Service area for commercial business)
Greatbatch Medical
Secondary
France
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants,
instruments and sterilization cases, trays and lids. (Corporate Headquarters, and the Sales,
Marketing, and Customer Service area for commercial business)
Greatbatch Medical
Single
Plymouth
MN
USA
ISO 13485/CMDCAS
Design and development, manufacture, contract manufacture, and distribution of active
implantable medical devices, Implantable Leads for AIMDs and related accessories,
Percutaneous Introducer Systems, Delivery Catheters, Sheaths, Safety Needles
andcomponents.
Greatbatch Medical
Primary
Clarence
NY
USA
ISO 13485/CMDCAS
Design, develoment, manufacturing, and distribution of orthopaedics and trauma implants,
instruments and sterilization cases, trays and lids.
Greatbatch Medical
Primary
Clarence
NY
USA
ISO 9001:2008
The design, manufacture and test of capacitors and lithium batteries for use in implantable
medical devices, and lithium ion rechargeable batteries for medical applications.
Greatbatch Medical
Single
Minneapolis
MN
USA
ISO 9001:2008
The Manufacture of Deep Drawn Device Enclosures, Cases, and Complex Stampings for
Implantable Medical Devices and other Commercial Applications.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The design, development, manufacture, distribution, installation and servicing of Holter
Recorder and Analysis Systems for Medical Applications.
Electronic Distributor, Third Party Logistics and Asset Recovery Provider
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Greatbatch Medical
Single
Clarence
NY
USA
EN ISO 13485:2012
Greatbatch Medical - Beaverton
Single
Beaverton
OR
USA
ISO 13485:2003
Greatbatch Medical Mexico,
Single
Tijuana, B.C.
Mexico
EN ISO 13485:2003
The Manufacture, Assembly and Testing of Components and Sub-Assemblies for Implantable
Medical Devices and other Medical Applications including Feedthroughs and Filtered
Feedthroughs and the Manufacture of non sterile, Acetabular Reamer orthopedicinstruments.
Greatbatch Medical SA
Single
Bienne
Switzerland
EN ISO 13485:2012
The Distribution of Orthopedic Medical Devices
Greatbatch, Inc.
Secondary
Alden
NY
USA
ISO 9001:2008
The design, manufacture and test of capacitors and lithium batteries for use in implantable
medical devices, and lithium Ion rechargeable batteries for medical applications.
Greatbatch, Inc.
Primary
Raynham
MA
USA
EN ISO 13485:2012
MD Scope: The design, manufacture, distribution and servicing of non implantable batteries
for medical device applications.ISO9K Scope: The Design and Manufacture of Specialty
Lithium Primary and Rechargeable Batteries and Battery Packs.
Greatbatch, Inc.
Secondary
Taunton
MA
USA
EN ISO 13485:2012
MD Scope: The design, manufacture, distribution and servicing of non implantable batteries
for medical device applications.ISO9K Scope: The design and manufacture and specialty
lithium primary and rechargeable batteries and battery packs.
GRL EMEA & EMEA Customer Q&R.
Single
Leixlip, County Kildare
Ireland
ISO 9001:2008
The provision of reverse logistics and customer quality and reliability support services for Intel
products in the EMEA region.
GStek, Inc.
Single
Chesapeake
VA
USA
ISO 9001:2008
Provisioning of Telecommunications, Information Technology, Program Management,
Logistics, Administration, and Engineering support services for government and commercial
contracts.
Guild Optical Associates
Single
Amherst
NH
USA
ISO 9001:2008
The manufacture, including grinding and polishing of windows, lenses and mirrors from glass
substrates and sapphire crystal
Hanson Research Corporation
Single
Chatsworth
CA
USA
ISO 9001:2008
The design, manufacture, installation and service of laboratory equipment.
Harbor MedTech
Single
Irvine
CA
USA
ISO 13485/CMDCAS
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The manufacturing and assembly of precision components and sub assemblies for medical
devices.
ISO9K: Design, manufacture and distribution of portable power solutions for electronic
devices.MD: Design, manufacture and distribution of portable power solutions for medical
devices.
Design, Manufacture and Distribution of stabilized (equine) collagen matrix products for wound
care.
4/10/2015
Profile
Type
CITY
Harmac Medical Products
Secondary
Castlerea Co.
Roscommon
Harmac Medical Products, Inc.
Secondary
Buffalo
Harmac Medical Products, Inc.
Primary
Buffalo
COMPANY
Harmac Medical Products, Inc.
STATE
Country
Scheme
Scope
The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical
Devices and Plastic Components Including Catheters, Infusion Sets for Oncology, Enteral
Feeding and Diagnostics and the Contract Manufacturing of Non-ActiveImplantable Medical
Devices Including Devices Containing Tissue of Animal Origin.
Ireland
EN ISO 13485:2012
NY
USA
ISO 14001:2004
NY
USA
EN ISO 13485:2012
The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical
Devices and Plastic Components Including Catheters, Infusion Sets for Oncology, Enteral
Feeding and Diagnostics and the Contract Manufacturing of Non-ActiveImplantable Medical
Devices Including Devices Containing Tissue of Animal Origin.
Mexico
EN ISO 13485:2012
The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical
Devices and Plastic Components Including Catheters, Infusion Sets for Oncology, Enteral
Feeding and Diagnostics and the Contract Manufacturing of Non-ActiveImplantable Medical
Devices Including Devices Containing Tissue of Animal Origin.
USA
AS 9100 - C
The design, manufacture and sale of precision gear reducers, servo-actuators and electromechanical positioning systems for use in aviation, space and defense.
The design, development, manufacture and contract manufacture of disposable medical
devices and plastic components and non-active implantable medical devices.
Secondary
Nueva Tijuana
Harmonic Drive L.L.C
Single
Peabody
HAWKER GmbH
Single
D-58089 Hagen
Germany
ISO 9001:2008
Development, production and sales of industrial batteries and aircraft NiCd batteries and
accessories
HAWKER GmbH
Single
D 58089 Hagen
Germany
ISO 14001:2004
Development, production and sales of industrial batteries and accessories
HAWKER GmbH
Single
D 58089 Hagen
Germany
OHSAS 18001:2007
Development, production and sales of industrial batteries and accessories
Hawker Powersource, Inc.
Single
Ooltewah
TN
USA
ISO 9001:2008
The design and manufacture of industrial batteries.
hcc Aegis
Single
New Bedford
MA
USA
ISO 9001:2008
The Manufacture of High Reliability Hermetic Glass to Metal Seal Packages for the
Microelectronics Industry.
HemCon Medical Technologies, Inc.
Single
Portland
OR
USA
ISO 13485/CMDCAS
The design and manufacture of chitosan-based hemorrhage control wound management
devices.
Hexavision SARL
Single
Paris
France
ISO 13485:2003
The design and development, manufacture and distribution of sterile intraocular lenses.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Hitachi Cable America, Inc.
Secondary
San Jose
CA
USA
ISO 9001:2008
Drawing and insulation of nonferrous wire, design and manufacture of copper and fiber optic
cable for the telecommunications, data and electronic markets.
Hitachi Cable America, Inc.
Single
Manchester
NH
USA
ISO 9001:2008
Drawing and insulation of nonferrous wire, design and manufacture of copper and fiber optic
cable for the telecommunications, data and electronic markets.
Hollister Incorporated
Single
Stuarts Draft
VA
USA
EN ISO 13485:2012
The manufacture of external use only, sterile and non-sterile, disposable medical devices
intended for ostomy, incontinence and wound care.
Hollister Incorporated
Single
Kirksville
MO
USA
EN ISO 13485:2012
The Manufacture of External Use Only, Sterile and Non-sterile, Medical Devices Intended for
Ostomy, Incontinence, Obstetrics/Gynaecology/Newborn/Paediatric and Wound Care
Products.
COMPANY
Scope
Hollister Incorporated
Primary
Libertyville
IL
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Nonsterile, Disposable Medical Devices Intended for Ostomy, Incontinence, Wound Care
Products and the Contract Manufacture of Sterile and Non-Sterile Obstetrics,Gynecology,
Newborn, and Pediatric Products.
Hollister Incorporated
Single
Libertyville
IL
USA
EN ISO 13485:2012
The Management of Manufacturers of Sterile and Non-Sterile External, Invasive, and
Disposable Medical Devices Intended for Ostomy, Incontinence, and Wound Care Products.
Hollister Medical India Private Limited
Single
Haryana
India
EN ISO 13485:2012
The Manufacture of Sterile & Non-Sterile Medical Devices for the treatment of Incontinence,
including Urinary Intermittent Catheters, Coude Taper Tip Urinary Intermittent Catheters,
Urinary Catheterization Systems, Urinary Catheterization Kits andCatheter Insertion Kits.
The Netherlands
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Nonsterile, Disposable Medical Devices Intended for Ostomy, Incontinence, Wound Care
Products and the Contract Manufacture of Sterile and Non-Sterile Obstetrics,Gynecology,
Newborn, and Pediatric Products.
Ireland
EN ISO 13485:2012
The design, manufacture and distribution of sterile and non-sterile ostomy and urinary
continence care prodcuts including catheters, ostomy pouches and related accessories.
Ireland
EN ISO 13485:2012
The manufacture, refurbishment, service and distribution of electronic devices for drug
infusion and enteral feeding.
Canada
ISO 13485:2003
The Distribution, Service, Repair and Remanufacture of Electronic Drug Infusion Devices and
Spare Parts.
Costa Rica
EN ISO 13485:2012
The manufacture of disposable sterile administration sets, infusion pump sets, critical care
products, catheter flush syringes and non-sterile components.The manufacture,
remanufacture, repair, service and distribution of electronic infusion devices, spare parts and
accessories.
Hollister Services BV
Secondary
Hollister ULC
Single
Rehins
Hospira
Single
Co. Sligo
Hospira Canada Service Center
Hospira Costa Rica Ltd.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary Saint-Laurent, Québec
Single
La Aurora de Heredia
Co. Mayo
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
Primary
Hospira Ltd.
COMPANY
Country
Scheme
Scope
Saint-Laurent, Quebec
Canada
EN ISO 13485:2012
The Distribution, Service, Repair and Remanufacture of Electronic Drug Infusion Devices and
Spare Parts.
Single
Itabo, Haina, San
Cristobal
Dominican Republic
EN ISO 13485:2012
The manufacture of sterile administration sets, feeding systems and non-sterile surgical
receptor devices.
Hospira, Inc.
Single
San Jose
CA
USA
EN ISO 13485:2012
The Remanufacture, Repair, Service and Distribution of Electronic Drug Infusion Devices and
Packaging and Distribution of Accessories Including Medical Software.
Hospira, Inc.
Single
Rocky Mount
NC
USA
EN ISO 13485:2012
The Provision of Irradiation Sterilization Services and Contract Irradiation Sterilization
Services for Medical Devices in Accordance with ISO 11137-1:2006
Houck Machine Company
Single
Plymouth
MN
USA
ISO 9001:2008
Hospira HealthCare Corporation - Canada
STATE
CNC Precision Machining Services and Mechanical Assemblies, Precision Machining of Metal
and Plastic Parts, CNC Milling and Turning Machining.
Design, Manufacture, and Distribution of Sterile Disposable Microkeratome Blades, Retinal
gases, Perfluorodecaline, Perfluorooctane, Implantable Silicone Retinal Oil, Sterile and NonSterile Ophthalmic Instruments (Trocars, Iris Retractors,Scleral plugs, Trephines, and
Cannulas).
Howard Instruments II, Inc.
Single
Tuscaloosa
AL
USA
EN ISO 13485:2012
Hutchinson Technology Inc.
Primary
Hutchinson
MN
USA
ISO 9001:2008
The design, development and manufacture of rigid disk drive components.
Hutchinson Technology Inc.
Secondary
Eau Claire
WI
USA
ISO 9001:2008
The design, development and manufacture of rigid disk drive components.
Hydroid, Inc
Single
Pocasset
MA
USA
ISO 14001:2004
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic
Systems.
Hydroid, Inc
Single
Pocasset
MA
USA
OHSAS 18001:2007
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic
Systems.
Hydroid, Inc
Single
Pocasset
MA
USA
ISO 9001:2008
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic
Systems.
HyperBranch Medical Technology, Inc
Single
Durham
NC
USA
EN ISO 13485:2012
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The design, development and manufacture of crosslinked hydrogel polymer sealants and
related delivery systems.
4/10/2015
COMPANY
Hyperion Inc.
ICU Medical de Mexico S.A. de C.V.
ICU Medical Slovakia s.r.o.
ICU Medical, Inc.
Profile
Type
CITY
STATE
Country
Scheme
Single
McLean
VA
USA
ISO 9001:2008
Secondary
Ensenada
Secondary
ISO 13485/CMDCAS
EN ISO 13485:2012
The design, manufacture, sterilization and distribution of intravenous catheters, IV
administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories,
enteral feeding valves, vial access devices,infusion sets and monitoring devices. The
manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation
sterilization of medical devices in accordance with ISO 11137-1:2006.
ISO 13485/CMDCAS
The design, manufacture, sterilization and distribution of intravenous catheters, IV
administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories,
enteral feeding valves, vial access devices,infusion sets and monitoring devices. The
manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation
sterilization of medical devices in accordance with ISO 11137-1:2006.
USA
ISO 13485/CMDCAS
The design, manufacture, sterilization and distribution of intravenous catheters, IV
administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories,
enteral feeding valves, vial access devices,infusion sets and monitoring devices. The
manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation
sterilization of medical devices in accordance with ISO 11137-1:2006.
Slovak Republic
Salt Lake City
UT
USA
ICU Medical, Inc.
Primary
San Clemente
IdentiGen Ltd
Primary
Dublin 2
Ireland
ISO 9001:2008
The Provision of analytical testing services (Traceback TM and Administration)
Identigen Ltd.
Secondary
Newport
United Kingdom
ISO 9001:2008
The provision of analytical testing services (Traceback TM and administration)
Single
Boston
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture and Distribution of ELISA Diagnostic Kits and
Microorganism Detection Systems.
ISO 13485/CMDCAS
The Design, Development and Manufacture of In-Vitro Diagnostic Reagents, and In-Vitro
Diagnostic Test Kits Used in the Diagnosis and/or Management of Cancer, Endocrine
Disorders, Fertility Testing, Immune Status, Autoimmune Diseases,and Bone Metabolism
Disorders.9K Scope: The Design, Development, Manufacture and Distribution of Research
Products.
Immunetics, Inc
Immunotech S.A.S
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single
Marseille, Cedex 9
CA
Management and Design of Information Technology Projects.
The design, manufacture, sterilization and distribution of intravenous catheters, IV
administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories,
enteral feeding valves, vial access devices,infusion sets and monitoring devices. The
manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation
sterilization of medical devices in accordance with ISO 11137-1:2006.
Mexico
Secondary
Scope
MA
France
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Czech Republic
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of In-Vitro Diagnostic Reagents, and In-Vitro
Diagnostic Test Kits used in the Diagnosis and/or Management of Cancer, Endocrine
Disorders, Fertility Testing,Immune Status, Autoimmune Status, Autoimmune Disease,
Prenatal Screening, Neonatal Screening, Diabetes, and Bone Metabolism Disorders.CMDCAS
Scope: The Design, Manufacture and Distribution of In-Vitro Diagnostic Reagents, and InVitro Diagnostic Test Kits used in the Diagnosis and/or management of endocrine disorders,
fertility testing and bone metabolism disorders.
Immunotech s.r.o.
Single
Prague
INFICON Inc.
Single
East Syracuse
NY
USA
ISO 9001:2008
The design and manufacture of residual gas analyzers, gas chromatograph/mass
spectrometers, thin film deposition monitors and controllers, and leak detectors.
INFICON Inc.
Single
East Syracuse
NY
USA
ISO 14001:2004
The design and manufacture of residual gas analyzers, gas chromatograph/mass
spectrometers, thin film deposition monitors and controllers, and leak detectors.
Infinity Components
Single
Portsmouth
NH
USA
ISO 9001:2008
The distribution of IC's and semiconductors. The provision of inventory management and
asset recovery programs.
Inmo-Tech Ltd.
Single
Co. Sligo
Ireland
EN ISO 13485:2012
MD Scope: Molding of medical device components, and assembly of components and
subassemblies for the medical device industry.ISO9K Scope: Contract Injection Moulding and
Manufacturing.
Innerstep
Single
Scotts Valley
CA
USA
I.S.EN ISO13485:2012
ISO 13485: Integrated supply chain management, manufacture, and test of electronic and
electromechanical systems and sub-systems for medical device industry.ISO 9001: Integrated
supply chain management, manufacture, and test of electronic and electromechanical
systems and sub-systems for original equipment manufactures.
Innovative Fabrication
Single
Lowell
MA
USA
ISO 9001:2008
Dicing and machining of any hard and brittle material for diverse applications including the
medical, microelectronics and optical industries.
InPress Technologies Inc.
Single
San Luis Obispo
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of non-active Women’s Health Care Products for
the Treatment of Post-Partum Hemmorage
INTA Technologies
Single
Santa Clara
CA
USA
AS 9100 - C
InTECHrity Inc
Single
Irvine
CA
USA
EN ISO 13485:2012
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Manufacture of electroplated and metallized ceramic and metal parts and assemblies.
Contract manufacturing of non-sterile therapeutic medical devices used in the treatment of
speech and swallowing disorders.
4/10/2015
COMPANY
Integrated Service Technology
Integrated Service Technology
Profile
Type
Secondary
Primary
CITY
Shenzhen
Shenzhen
STATE
Country
China
China
Scheme
Scope
IECQ ITL
Environmental and reliability testing for passive, active and electromechanical components,
(IEC60068, IEC 60529, IPC-A-610, MIL-STD 202, MIL-STD-810, MIL-STD-883, JESD-22
series, ANSI/ESD STM 5.1, 5.2, 5.3.1, ISTA 2A, BELL Core GR-63, J-STD-020),including
Free fall test, High temperaure test, Humidity storage test, Low pressure, Altitude test, Low
temperature test, Mechanical shock test, Mixed flowing gas test, Salt spray test, Solar
radiation test, Temperature cycling test, Thermal shocktest, Vibration test, High Temperature
Operating Life test and Dye penetration test.
IECQ ITL
The failure analysis test of PCBA and electromechanical components (by standards of IPCTM-650 2.1.1, IPC-A-600, IPC-A-610, IPC-6012, J-STD-035, J-STD-020, JESD22A121,
JESD201, and MIL-STD-883), including Cross section test,Scanning accoustic microscope
test, X-ray/ Radiography test, Scanning electron microscope test, Visual inspection test,
Focused ion beam test, Emission microscope test, Probe test, Electrostatic discharge test
(HBM/MM), andLatch-up test.
Environmental and reliability testing, inspection and failure analysis (by standards of IEC
60068, MIL-STD-202, MIL-STD-810, MIL-STD-883, JESD-22 series, ANSI/ESD
STM5.1/5.2/5.3, BELL Core GR-63, J-STD-020, AEC-Q100, AEC-Q101, IPC-TM-650, IPC-A600, IPC-A-610, IPC-6012, J-STD-035, JESD201, EIAJ ED-4701),
Including tests of:
Integrated Service Technology Inc
Secondary
Shanghai City
China
IECQ ITL
Electrostatic discharge test (HBM/MM/CDM), External visual, Emission microscope, Focused
Ion Beam, Highly Accelerated Temperature and Humidity Stress test, High Temperature
Storage Life, Humidity storage, Latch-up, Low Temperature Storage Life, Micro section,
Moisture Reflow Sensitivity Classification for Nonhermetic Solid State Surface Mount Devices,
Preconditioning of Nonhermetic Surface Mount Device Prior To Reliability, Probe station,
Accelerated Moisture Resistance Unbiased Autoclave(Pressure cook), Scanning electron
microscope, Temperature and Humidity Bias Life, Temperature Bias and Operating Life,
Temperature cycling, Thermal shock, Cycled Temperature Humidity Bias Life, Accelerated
Moisture Resistance -Unbiased HAST.
Environmental and reliability testing, inspection and failure analysis (by standards of IEC
60068 / 60529; ISO 105 / 7253 / 7384 / 9022 / 9227 / 10060 / 11341 /12097 / 14892 /16750 /
20653; IPC-A-600 / 610 / 6012; IPC-TM-650; ISTA; EIAJ ET-7401/7402; EIA-364; MIL-STD202 / 810 / 883; ASTM B117 / D1735 / D2247 / D3002 / D5894 / G85/ G155; JESD-22 series;
JESD 201; J-STD-002 / 003 / 004 / 020 / 035; JIS Z 3197 / 3198; JIS D 0203; DIN 75220 /
40050-9; GB 2423 /8410 / 10485; GB/T 9491 / 19949 ; DELL sepc; VW 80101; GMW 3172;
MGRES:62.21.001; BMW GS 95003; BMW GS 95011; PSA B2117130; Nissan 24012NDS04;
FMVSS 571.302, SAE J1885/J2412/J1960/J2527, AATCC 16-3/169-1, TL-226, DIN EN ISO
1518 / 2409), Including tests of:
Integrated Service Technology Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Jiangsu
China
IECQ ITL
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Compression; Dye penetration; External visual; Flammability; Free fall; Highly accelerated
temperature and humidity stress; Highly Accelerated Life; High temperature; Humidity; Low air
pressure (altitude); Low temperature; Micro section; Flowing mixed gas corrosion; Moisture
sensitivity levels; Pressure cook; Shear and Pull; Radiography(X-ray); Salt spray; Degrees of
protection (dust and rain); Scanning acoustic microscope; Scanning electron microscope;
Shock; Solar radiation; Insulation resistance; Electrochemical migration; Conductive anodic
filament; Thermal shock; Vibration; Wetting balance/Solderability; Temperature/humidity
cyclic; Mould growth; Dew test; Chemical resistance; and Xenon arc lamp test; Abrasion
behaviour; Crosscut; and Scratch resistance.
4/10/2015
COMPANY
Integrated Service Technology Inc.
Integrated Service Technology, Inc.
Profile
Type
CITY
Secondary
Hsin-Chu City 300
Single
Pine Lake
STATE
GA
Country
Scheme
Taiwan, R.O.C.
IECQ ITL
Taiwan, R.O.C.
IECQ ITL
Scope
Environmental and reliability testing (International Standard & MIL-STD-810, etc), including
Low temperature test, High temperature test, Humidity storage test,Temperature cycling test,
Thermal shock test, Pressure cook test, and Highly accelerated temperature and humidity
stress test.
1. Environmental and reliability testing (JEDEC, AEC-Q100/Q101/Q200 , IEC 60529, IEC
60068-2 -1 to IEC 60068-2 -64, Mil-STD-810 & Mil-STD-883) Electrostatic discharge test, Low
temperature, High temperature test, Humidity storage test, Temperature cycling test, Thermal
shock test, Pressure cook test, Highly Accelerated Temperature and Humidity Stress test
(JESD22 A110), Low pressure, altitude test, Temperature and Humidity Bias Life test,
Temperature, Bias and Operating Life test (JESD22 A108), Rain test, Salt spray test, Mixed
flowing gas test, Solar radiation test, Sand and dust test, Preconditioning of Nonhermetic
Surface Mount Device Prior To Reliability Testing, Surface Insulation Resistance and
Electrochemical Migration, Solderability (wetting Balance) test, Vibration test, Shock test, Free
fall test, Acoustic noise test and LED Luminaries test, IC EMC test, Gate Leakage test,
Endurance & Data Retention test and Power & Temperature cycling test and Early Life Failure
Rate Test (AEC Q100-008).
2. Failure analysis and material analysis of semiconductor integrated circuits, electronic
components and PCB/PCBA, including FIB (Focused Ion Beam), Electrical Analysis, Sample
Preparation (Decap, X-section, etc), NDE (Non-destructive Engineering), Physical & Chemical
Analysis (Including Hazardous Substances) and IC package.
3. 2nd Level Integration Platform Service, including SMT and 2nd reliability Services
(Temperature Cycle (IPC9701) Test, Board Level Drop Test, Shock Test, Vibration Test,
Bending Test (Cyclic bend & Monotonic bend (IPC9702)), Pull/Push Test and SMT and PCBA
test (Cold ball pull test, wire pull test, ball shear test and hot bond pull test)).
Intel Corporation
Primary
Santa Clara
CA
USA
OHSAS 18001:2007
The Manufacture of Semiconductors.
Intel Corporation
Secondary
Chandler
AZ
USA
OHSAS 18001:2007
The manufacturing of semi-conductors.
Intel Corporation
Secondary
Hudson
MA
USA
OHSAS 18001:2007
The manufacturing of semiconductors.
Intel Corporation
Secondary
Rio Rancho
NM
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation
Secondary
Hillsboro
OR
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation
Secondary
Dalian, LN
China
ISO 9001:2008
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Wafer Fabrication, Associated Equipment and Processes.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Intel Corporation
Secondary
Santa Clara
CA
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation
Secondary
Chandler
AZ
USA
ISO 14001:2004
The manufacturing of semi-conductors.
Intel Corporation
Single
Chandler
AZ
USA
ISO 9001:2008
Distribution of microprocessors.
Intel Corporation
Primary
Chandler
AZ
USA
ISO 9001:2008
Design, Develop, Assemble and Test Semiconductor Components, Associated Equipment
and Processes.
Intel Corporation
Secondary
Hillsboro
OR
USA
ISO 14001:2004
The manufacturing of semiconductors.
Intel Corporation
Secondary
Hudson
MA
USA
ISO 14001:2004
The manufacturing of semiconductors.
Intel Corporation
Secondary
Rio Rancho
NM
USA
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation
Secondary
Aloha
OR
USA
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation
Secondary
Chandler
AZ
USA
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation
Primary
Santa Clara
CA
USA
ISO 14001:2004
The manufacturing of semi-conductors.
Intel Corporation
Secondary
Rio Rancho
NM
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation
Secondary
Aloha
OR
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Intel Corporation
Secondary
Aloha
OR
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation
Secondary
Chandler
AZ
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation - ATTD
Secondary
Chandler
AZ
USA
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation - D1C
Secondary
Hillsboro
OR
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation - Fab 17
Secondary
Hudson
MA
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation - Fab 24
Secondary
Leixlip, County Kildare
Ireland
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation - Fab 28 and IDPj
Secondary
Qiryat Gat
Israel
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes
Intel Corporation - Fab 32
Secondary
Chandler
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation - KMCO
Secondary
Kulim, Kedah
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation - KMO
Secondary
Kulim
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation - SIMS - System
Secondary
Kedah Darul Aman
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation ATTD
Secondary
Hillsboro
USA
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
AZ
Kedah
OR
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
Chandler
AZ
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Secondary
Penang
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Single
Amsterdam
The Netherlands
ISO 9001:2008
The distribution and storage of all Finished Goods for the Europe, Middle East and Africa
(EMEA) region.
Intel Ireland Ltd.
Secondary
Leixlip, County Kildare
Ireland
OHSAS 18001:2007
The manufacturing of semiconductors.
Intel Ireland Ltd.
Secondary Leixlip, County Kildare
Ireland
ISO 14001:2004
The manufacturing of semiconductors
Intel Israel
Secondary
Qiryat Gat
Israel
ISO 14001:2004
The manufacturing of semiconductors
Intel Israel
Secondary
Qiryat Gat
Israel
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Israel International Die
Secondary
Jerusalem
Israel
ISO 14001:2004
Intel Israel International Die
Secondary
Jerusalem
Israel
OHSAS 18001:2007
Intel Israel International Die
Secondary
Jerusalem
Israel
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes
Intel Products (Chengdu) Ltd
Secondary
Chengdu, Sichuan
China
ISO 14001:2004
The manufacture of semiconductors
Intel Products (Chengdu) Ltd
Secondary
Chengdu, Sichuan
China
OHSAS 18001:2007
COMPANY
Intel Corporation-Fab/Sort Manufacturing
Intel Corporation-PG AT
Intel International BV
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The manufacturing of semi-conductors.
The Manufacture of Semiconductors.
The manufacturing of semiconductors
4/10/2015
Profile
Type
CITY
Single
Intel Products (Chengdu) Ltd - CD6
COMPANY
Country
Scheme
Chengdu
China
ISO 50001
Secondary
Chengdu, Sichuan
China
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Products (Chengdu) Ltd. - CDCO
Secondary
Chengdu, Sichuan
China
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Products (M) Sdn. Bhd.
Secondary
Kulim
Kedah
Malaysia
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Products (M) Sdn. Bhd.
Secondary
Kulim
Kedah
Malaysia
ISO 14001:2004
The manufacturing of semiconductors
Intel Products Vietnam
Secondary
Ho Chi Minh City
Vietnam
ISO 9001:2008
Site Specific Scope: Assemble and Test Semiconductor Components, Associated Equipment
and Processes.Main Cert Scope: Design, Develop, Assemble and Test Semiconductor
Components, Associated Equipment and Processes.
Intel Products Vietnam
Single
Ho Chi Minh City
Vietnam
ISO 50001
Intel Products Vietnam, Ltd.
Secondary
Ho Chi Minh City
Vietnam
ISO 14001:2004
The manufacturing of semiconductors
Intel Products Vietnam, Ltd.
Secondary
Ho Chi Minh City
Vietnam
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Semiconductor (Dalian) Ltd.
Secondary
Dalian, LN
China
ISO 14001:2004
Manufacturing of semiconductors.
Intel Semiconductor (Dalian) Ltd.
Secondary
Dalian, LN
China
OHSAS 18001:2007
Manufacturing of semiconductors.
Intel Technology Sdn. Bhd.
Secondary
Penang
Malaysia
OHSAS 18001:2007
The manufacture of semi-conductors.
Intel Products (Chengdu) Ltd
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Manufacture assembly and test of semiconductors.
Assembly and Test of Semiconductor Components, associated equipment and processes.
4/10/2015
Profile
Type
CITY
Intel Technology Sdn. Bhd.
Secondary
Penang
Intel-GE Care Innovations, LLC
Secondary
Roseville
Intel-GE Care Innovations, LLC
Primary
International Titanium Corporation
COMPANY
Country
Scheme
Malaysia
ISO 14001:2004
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacturing and Distribution, and Service of Health Information
Systems to Aggregate and Transmit Data for Patient Care Management
Roseville
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacturing and Distribution, and Service of Health Information
Systems to Aggregate and Transmit Data for Patient Care Management
Single
New Brighton
PA
USA
ISO 9001:2008
Provision of saw cutting and grinding of metals in customer supplied form.
Interroll Engineering West Inc.
Single
Canon City
CO
USA
ISO 9001:2008
The design and manufacture of conveyors and conveying equipment.
Intersect ENT
Single
Menlo Park
CA
USA
ISO 13485/CMDCAS
Interstate Manufacturing Associates, Inc
Single
Newport
NH
USA
ISO 9001:2008
Manufacture and sales of machined parts and assemblies for commercial and industrial use.
Interventional Spine, Inc.
Single
Irvine
CA
USA
EN ISO 13485:2012
The design, manufacture and distribution of orthopedic bone fixation devices and associated
non-sterile manual surgical instruments.
Intuitive Research & Technology Corp.
Single
Huntsville
AL
USA
ISO 9001:2008
iRhythm Technologies, Inc.
Secondary
Lincolnshire
IL
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph
(ECG) monitors, and associated analysis software. The Provision of ECG data recovery,
analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
Secondary
Huntington Beach
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph
(ECG) monitors, and associated analysis software. The Provision of ECG data recovery,
analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
Primary
San Francisco
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph
(ECG) monitors, and associated analysis software. The Provision of ECG data recovery,
analysis, and report generation services for physicians.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The manufacture of semi-conductors.
The Design and Development, Manufacturing and Distribution of Sinus Stents and Drug
Coated Sinus Stents.
Technical and engineering services, and the provision of management and technical services,
programmatic support, system engineering, quality management, engineering and production
systems support, and technology management solutions tothe Department of Defense,
government agencies and commercial customers.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Irvine Scientific
Primary
Santa Ana
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical
Devices Consisting of Tissue Culture Products and In-Vitro Diagnostics for use with IVF, and
Assisted Reproductive Products for In-Vitro Fertilization use.
Irvine Scientific
Secondary
Santa Ana
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical
Devices Consisting of Tissue Culture Products and In-Vitro Diagnostics for use with IVF, and
Assisted Reproductive Products for In-Vitro Fertilization use.
Irvine Scientific
Secondary
Santa Ana
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical
Devices Consisting of Tissue Culture Products and In-Vitro Diagnostics for use with IVF, and
Assisted Reproductive Products for In-Vitro Fertilization use.
Irvine Scientific - Ireland
Single
Co. Wicklow
Ireland
EN ISO 13485:2012
The storage and distribution of medical devices consisting of tissue culture products. In Vitro
Diagnostics such as Amniostat for Foetal Lung Maturity, and Assisted Reproductive Products
for use in In Vitro Fertilisation use
I-TEK Medical Technologies
Single
St. Paul
MN
USA
EN ISO 13485:2012
Contract design and manufacturing services for sterile and non-sterile medical devices and
medical device assemblies.
Ivantis, Inc.
Single
Irvine
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Implantable Ophthalmic Devices for
Treatment of Glaucoma.
JACER Corporation
Single
Fairfax
VA
USA
ISO 9001:2008
JACER Corporation Provides the Federal Government with Support Services that include:
Program and Project Management, Financial and Business Support Management,Logistics
and Resource Management, Administrative Support Services, Strategic Consulting, and Total
Information Management/Information Technology Solutions.
JL Precision
Single
San Jose
CA
USA
ISO 9001:2008
Precision Sheet Metal, CNC Machining and Custom Framing
Jones Lang LaSalle
Single
Royal Oak
MI
USA
ISO 9001:2008
Delivery of Facility Management Services at Client Facilities.
Judson A. Smith Company
Single
Boyertown
PA
USA
ISO 9001:2008
The Manufacture of Metal Components for Medical/Orthopaedic, Aerospace, Automotive and
Electronics Industries.
Jus-Com Telecommunications, Inc.
Single
Indianapolis
IN
USA
TL 9000 R5.0/5.0
TL9000-V Scope: Network Element Integration Service for the following category 7.1.1 InstallationISO9K Scope: Network Element Integration Service
KAPP Surgical Instrument, Inc.
Single
Warrensville Heights
OH
USA
EN ISO 13485:2003
Design, Manufacture, Service and Distribution of Reusable Instruments and Surgical
Accessories used for Cardiovascular and Orthopaedic,Implantable Gastric Radiographic
Marker, Small Joint Orthopaedic Prostheses Implant, and Sterile Surgical Securement
Device.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Chesterfield
MO
USA
ISO 13485/CMDCAS
Kimball Electronics Inc. - Jasper
Primary
Jasper
IN
USA
AS 9100 - C
The provision of electronics manufacturing services including Test Development and Support,
New Product Introduction, SMT, Thru-hole (including RoHS), Conformal Coating, and Printed
Circuit Board Assembly (PCBA) for the Aviation, Space and DefenseIndustries.
Kimball Electronics, Inc. - Jasper
Secondary
Jasper
IN
USA
AS 9100 - C
The provision of electronics manufacturing services including Test Development and Support,
New Product Introduction, SMT, Thru-hole (including RoHS), Conformal Coating, and Printed
Circuit Board Assembly (PCBA) for the Aviation, Space and DefenseIndustries.
EN ISO 13485:2003
MD Scope: The Provision of Electronic Manufacturing and Assembly Services for the Medical
Industry, Including the Subcontract Manufacture of Cranial Electrotherapy Stimulator
Devices.ISO9K Scope: An electronics manufacture service provider for contract
manufacturing services for the computer, industrial, medical, public safety,
telecommunications and transportation industries.
MD Scope: The Provision of Electronic Manufacturing and Assembly Services for the Medical
Industry, Including the Subcontract Manufacture of Cranial Electrotherapy Stimulator
Devices.ISO9K Scope: An electronics manufacture service provider for contract
manufacturing services for the computer, industrial, medical, public safety,
telecommunications and transportation industries.
COMPANY
Katalyst Surgical, LLC
Kimball Electronics, Inc. – Jasper
Kimball Electronics, Inc. – Jasper
Primary
Jasper
IN
USA
Scope
The Design, Manufacture, and Distribution of Sterile and Non-Sterile Instruments and
Accessories for Opthalmic, Neurosurgery, and General Surgery.
Secondary
Jasper
IN
USA
EN ISO 13485:2003
Primary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office - Jasper
Secondary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office - Jasper
Secondary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office - Salem
Secondary
Salem
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office Products - Post Falls
Secondary
Post Falls
ID
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Single
Paris
France
TL 9000 R5.0/5.0
Kimball Office - CMG
Laboratoire Européen ADSL (LEA)
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
TL9000-H Scope: DESIGN, MANUFACTURING, TESTING AND SALES OF ELECTRONIC
CARDS FOR BROADBAND COMMUNICATION ( XDSL Technologies); Product Category:
6.2.3.1 Data Modems
4/10/2015
COMPANY
Lake Region Medical
Lake Region Medical
Lake Region Medical
Lake Region Medical
Lake Region Medical
Profile
Type
Primary
Secondary
Secondary
Secondary
CITY
Chaska
Chaska
Chaska
Chaska
STATE
MN
MN
MN
MN
Scheme
Scope
ISO 13485/CMDCAS
MD: The Design, Development, Manufacture and Distribution of Sterile and Non-Sterile
Guidewires for the Areas of Gastroenterology/Urology and Vascular Guidewires for Peripheral
and Cardiac use, Torque Devices, Stylets, Biopsy Instruments,Custom Metal Coils and
Machined Medical Components. Contract Manufacturing of Stents and Stent Delivery
Systems.CMDCAS: The design, development, manufacture and distribution of sterile and nonsterile guidewires for the areas of gastroenterology/urology and vascular guidewires for
peripheral and cardiac use.
ISO 13485/CMDCAS
MD: The Design, Development, Manufacture and Distribution of Sterile and Non-Sterile
Guidewires for the Areas of Gastroenterology/Urology and Vascular Guidewires for Peripheral
and Cardiac use, Torque Devices, Stylets, Biopsy Instruments,Custom Metal Coils and
Machined Medical Components. Contract Manufacturing of Stents and Stent Delivery
Systems.CMDCAS: The design, development, manufacture and distribution of sterile and nonsterile guidewires for the areas of gastroenterology/urology and vascular guidewires for
peripheral and cardiac use.
ISO 13485/CMDCAS
MD: The Design, Development, Manufacture and Distribution of Sterile and Non-Sterile
Guidewires for the Areas of Gastroenterology/Urology and Vascular Guidewires for Peripheral
and Cardiac use, Torque Devices, Stylets, Biopsy Instruments,Custom Metal Coils and
Machined Medical Components. Contract Manufacturing of Stents and Stent Delivery
Systems.CMDCAS: The design, development, manufacture and distribution of sterile and nonsterile guidewires for the areas of gastroenterology/urology and vascular guidewires for
peripheral and cardiac use.
ISO 13485/CMDCAS
MD: The Design, Development, Manufacture and Distribution of Sterile and Non-Sterile
Guidewires for the Areas of Gastroenterology/Urology and Vascular Guidewires for Peripheral
and Cardiac use, Torque Devices, Stylets, Biopsy Instruments,Custom Metal Coils and
Machined Medical Components. Contract Manufacturing of Stents and Stent Delivery
Systems.CMDCAS: The design, development, manufacture and distribution of sterile and nonsterile guidewires for the areas of gastroenterology/urology and vascular guidewires for
peripheral and cardiac use.
USA
ISO 13485/CMDCAS
MD: The Design, Development, Manufacture and Distribution of Sterile and Non-Sterile
Guidewires for the Areas of Gastroenterology/Urology and Vascular Guidewires for Peripheral
and Cardiac use, Torque Devices, Stylets, Biopsy Instruments,Custom Metal Coils and
Machined Medical Components. Contract Manufacturing of Stents and Stent Delivery
Systems.CMDCAS: The design, development, manufacture and distribution of sterile and nonsterile guidewires for the areas of gastroenterology/urology and vascular guidewires for
peripheral and cardiac use.
USA
USA
USA
USA
Secondary
Chaska
Lake Region Medical Ltd
Single
Co Wexford
Ireland
OHSAS 18001:2007
The design & development, manufacture and distribution of sterile and non-sterile guidewires
used in peripheral and cardiac applications
Lake Region Medical Ltd
Single
Co. Wexford
Ireland
ISO 14001:2004
The design & development, manufacture and distribution of sterile and non-sterile guidewires
used in peripheral and cardiac applications
Lake Region Medical Ltd.
Single
New Ross
Co. Wexford
Ireland
ISO 13485/CMDCAS
Secondary
Livermore
CA
USA
ISO 9001:2008
Lam Research Corporation
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MN
Country
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The Design & Development, Manufacture and Distribution of Sterile and Non-Sterile
Guidewires Used in Peripheral and Cardiac Applications.
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Lam Research Corporation
Secondary
Livermore
CA
USA
ISO 14001:2004
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Single
San Jose
CA
USA
ISO 9001:2008
The design, development, manufacture and service of semiconductor production equipment
used in the semiconductor manufacturing industry.
Lam Research Corporation
Single
San Jose
CA
USA
ISO 14001:2004
The environmental activities and supporting processes associated with the design,
development, manufacture and servicing of semiconductor production equipment used in the
semiconductor manufacturing industry of their products and services.
Lam Research Corporation
Primary
Fremont
CA
USA
ISO 9001:2008
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Primary
Fremont
CA
USA
ISO 14001:2004
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Secondary
Tualatin
OR
USA
ISO 9001:2008
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Secondary
Tualatin
OR
USA
ISO 14001:2004
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Single
Fremont
CA
USA
OHSAS 18001:2007
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lamar Tool & Die Casting, Inc.
Single
Modesto
CA
USA
ISO 9001:2008
The production and distribution of aluminum, brass and zinc die cast products.
Lamb Depollution
Single
Hooks
TX
USA
ISO 14001:2004
The collection and disposition of automotive liquids and fuels.
Lampin Corporation
Single
Uxbridge
MA
USA
ISO 9001:2008
Manufacture of Precision Mechanical Components and Assemblies.
Primary
Montebello
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services including Custom and Stock Packaging
Products and related Machinery, Janitorial Supplies, Design Services and Turn Key
Assembly.
COMPANY
Landsberg
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Landsberg - Atlanta
Secondary
Atlanta
GA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies and Turn Key Assembly.
Landsberg Dallas
Secondary
Grapevine
TX
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg Denver
Secondary
Aurora
CO
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg EPS Southwest
Secondary
Montebello
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design Services.
Landsberg Fresno
Secondary
Fresno
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg Guadalajara
Secondary
Zapopan, Jalisco
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services including Custom and Stock Packaging
Products and related Machinery and Janitorial Supplies.
Landsberg Houston
Secondary
Houston
TX
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery,and Janitorial Supplies.
Landsberg Indianapolis
Secondary
Indianapolis
IN
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies, and Design Services.
Landsberg Juarez
Secondary
Chihuahua
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design Services.
Landsberg Memphis
Secondary
Memphis
TN
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg Mexicali
Secondary
Mexicali
Baja
California
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Turn Key Assembly.
Landsberg New Jersey
Secondary
Cranbury
NJ
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Landsberg Ontario (CA)
Secondary
Fontana
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design Services.
Landsberg Orange County
Secondary
Buena Park
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design Services.
Landsberg Orora Chicago
Secondary
Lombard
IL
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design Services.
Landsberg Phoenix
Secondary
Phoenix
AZ
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg Portland
Secondary
Wilsonville
OR
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies, Design Services and Turn Key
Assembly.
Landsberg Sacremento
Secondary
Rocklin
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies, Design Services and Turn Key
Assembly.
Landsberg San Diego
Secondary
San Marcos
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies, Design Services and Turn Key
Assembly.
Landsberg San Jose
Secondary
Newark
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies, and Design Services.
Landsberg Santa Barbara
Secondary
Oxnard
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design.
Landsberg Seattle
Secondary
Kent
WA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg St. Louis
Secondary
Earth City
MO
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies.
Landsberg Tijuana
Secondary
Tijuana, BC
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery, Janitorial Supplies and Design Services.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Lastar, Inc.
Secondary
Dayton
OH
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable
assemblies for the telecommunications and data networking industries.
Lastar, Inc.
Primary
Moraine
OH
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable
assemblies for the telecommunications and data networking industries
Lastar, Inc.
Secondary
Albia
IA
USA
ISO 9001:2008
The sale of fiber optic, copper, and audio/video cable assemblies for the telecommunications
and data networking industries
Lastar, Inc.
Secondary
Hickory
NC
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable
assemblies for the telecommunications and data networking industries
Latva Machine, Inc.
Single
Newport
NH
USA
ISO 9001:2008
Precision machining and turning facility specializing in complex components and assemblies
from exotic material in bar stock, plate, casting and forging material for the Aerospace, Military
and Commercial applications.
Le Belge Chocolatier
Single
Napa
CA
USA
ISO 9001:2008
The Manufacture of Customized European Style Chocolates.
LFI Inc.
Secondary
Walpole
MA
USA
I.S.EN ISO13485:2012
The Contract manufacturing and machining of medical device components, and contract
assembly and packaging of medical devices.
LFI Inc.
Primary
Smithfield
RI
USA
EN ISO 13485:2012
The Contract manufacturing and machining of medical device components, and contract
assembly and packaging of medical devices.
Single
Braintree
MA
USA
EN ISO 13485:2012
The design, manufacture, service and distribution of reusable hand-held surgical
instrumentation.
USA
ISO 13485/CMDCAS
The contract Design, Manufacturing, package testing, warehousing, distribution, cleaning and
decontamination of non-active invasive and non-invasive surgical devices, diagnostic
equipment and active electro-medical device including surgical andmonitoring probes,
contract moist heat sterilization services in accordance with ISO 17665-1:2006 and contract
ethylene oxide sterilization services in accordance with ISO 11135:2007.
Canada
EN ISO 13485:2012
Design and development of active platelet quality testing systems and non-active sterile and
non-sterile sampling sets.
USA
ISO 9001:2008
COMPANY
Life Instrument Corporation
Life Science Outsourcing, Inc.
Single
Brea
LightIntegra Technology Inc.
Single
Vancouver BC
Linear & Metric Co
Single
Londonderry
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
NH
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Sales and Production of Machined Products.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Single
Everett
MA
USA
ISO 9001:2008
Manufacture and Repair of Hand-Held Surgical Instruments for Various Surgical Applications.
LTX-Credence Corporation
Secondary
Milpitas
CA
USA
ISO 9001:2008
The design, development, manufacture, installation and service support of linear, digital,
mixed signal and discrete semiconductor test equipment and associated applications in the
North America, Europe and Asia.
LTX-Credence Corporation
Primary
Norwood
MA
USA
ISO 9001:2008
The design, development, manufacture, installation and service support of linear, digital,
mixed signal and discrete semiconductor test equipment and associated applications in North
America, Europe and Asia.
Lumen Dynamics
Single
Ontario
Canada
ISO 9001:2008
Design and manufacture of precision light sources and delivery systems for use in
photochemical and illumination applications.
Lumen Dynamics
Single
Ontario
Canada
ISO 14001:2004
Design, manufacture and service of precision light sources and delivery systems for use in
photochemical and illumination applications.
Lumigen, Inc.
Single
Southfield
MI
USA
ISO 9001:2008
Design, Development and Manufacture of Chemiluminescent Reagents.
Lumitex Medical Devices, Inc.
Secondary
Strongsville
OH
USA
ISO 13485/CMDCAS
Design and Development, Production, Contract Manufacturing and Distribution of Sterile and
Non-sterile Medical Illumination Devices and Non-sterile Phototherapy Devices.
Lumitex Medical Devices, Inc.
Primary
Strongsville
OH
USA
ISO 13485/CMDCAS
Design and Development, Production, Contract Manufacturing and Distribution of Sterile and
Non-sterile Medical Illumination Devices and Non-sterile Phototherapy Devices.
Lumitex, Inc
Secondary
Strongsville
OH
USA
EN ISO 13485:2012
Design and Development, Production and Distribution of Medical Illumination Devices and
Phototherapy Devices.
Lumitex, Inc.
Primary
Strongsville
OH
USA
EN ISO 13485:2012
Design and Development, Production and Distribution of Medical Illumination Devices and
Phototherapy Devices.
Lunarline
Single
Arlington
VA
USA
ISO 9001:2008
Development and delivery of cyber security and privacy solutions to include services, training
and products.
Lynch Medical Supplies (LMS) LTD
Single
Co. Dublin
Ireland
EN ISO 13485:2012
The manufacture and supply of non-sterile crepe and conforming bandages and the supply of
related medical disposables.
COMPANY
Logan Instruments Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
M & M Qualtech Ltd
Single
M & M Qualtech Ltd.
M/A-COM Technology Solutions Inc
COMPANY
Country
Scheme
Scope
Co Galway
Ireland
EN ISO 13485:2012
The Sub-Assembly manufacture, Assembly and System integration of non-invasive Medical
Devices such as Printed Circuit Board Assemblies, muscle stimulants and respiratory
products: the manufacture of Medical Device interface cables, and themanufacture of invasive
Refulx Control products.
Single
Co Galway
Ireland
ISO 9001:2008
The Manufacture of Electronic Products and Wiring Harnesses. Supply Chain Management:
including procurement, materials management, pick/pack ship, and customer order fulfillment
Single
Nashua
NH
USA
ISO 9001:2008
Contract Manufacture of Micro Electronics, RF/Microwave Components.
Maintech
Primary
Cranford
NJ
USA
ISO 9001:2008
IT Infrastructure Support Services
Maintech
Secondary
Wallington
NJ
USA
ISO 9001:2008
IT Infrastructure Support Services
Manufactured Packaging Products Group
Primary
Fullerton
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted and laminated corrugated containers, inserts, partitions, display and related
corrugated products.
Manufactured Packaging Products Group
Secondary
Alhambra
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted corrugated containers, labeled corrugated containers, inserts and laminated
inserts, partitions, display and related corrugated products.
Manufactured Packaging Products Group
Secondary
San Marcos
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted and laminated corrugated containers, inserts, partitions, display and related
corrugated products.
Manufactured Packaging Products Group
Secondary
Brea
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted and laminated corrugated containers, inserts, partitions, display and related
corrugated products.
Manufactured Packaging Products Group
Secondary
Newark
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted corrugated containers, labeled corrugated containers, inserts and laminated
inserts, partitions, display and related corrugated products.
Manufactured Packaging Products Group
Secondary
Union City
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted and laminated corrugated containers, inserts, partitions, display and related
corrugated products.
Manufactured Packaging Products Group
Secondary
Sycamore
IL
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers,
preprinted and laminated corrugated containers, inserts, partitions, display and related
corrugated products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Manufacturing Technology Group
Single
Westfield
MA
USA
ISO 9001:2008
MAR COR Purification
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
Marathon Abrasive Company, Inc
Single
Chester
SC
USA
ISO 9001:2008
Mar-Med Co.
Single
Grand Rapids
MI
USA
EN ISO 13485:2012
The Design, Development, Manufacture and Distribution of Sterile Tourniquet Devices for
Digit Surgery and Non-sterile Cast Protectors.
Marvao Medical Devices Ltd
Single
Galway
Ireland
EN ISO 13485:2012
The design and manufacture of sterile, implantable and non-implantable vascular access
devices andaccessories.
Mass Design
Single
Nashua
NH
USA
EN ISO 13485:2012
MD Scope: The Manufacture and Assembly of Printed Wiring Boards for the Medical
Industry.ISO9K Scope: Layout, Fabrication and Assembly of Printed Circuit Boards
MASS Precision Mexico S de RL de CV
Secondary
El Salto, Jalisco
Mexico
ISO 9001:2008
Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal
Components, Assemblies and Electro-Mechanical Assemblies.
MASS Precision, Inc.
Secondary
San Jose
CA
USA
ISO 9001:2008
Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal
Components, Assemblies and Electro-Mechanical Assemblies.
MASS Precision, Inc.
Secondary
San Jose
CA
USA
ISO 9001:2008
Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal
Components, Assemblies and Electro-Mechanical Assemblies.
MASS Precision, Inc.
Primary
San Jose
CA
USA
ISO 9001:2008
Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal
Components, Assemblies and Electro-Mechanical Assemblies.
MASS Precision, Inc.
Secondary
Santa Clara
CA
USA
ISO 9001:2000
Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal
Components, Assemblies and Electro-Mechanical Assemblies.
MASS Precision, Inc.
Single
Santa Clara
CA
USA
EN ISO 13485:2012
Contract Design, Manufacturing, System Integration and Testing of Metal Components,
Assemblies and Electro-Mechanical Assemblies for (Non-Sterile) Medical Application.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Fabrication of metal goods for the commercial and industrial marketplace.
Design, Manufacturing, Installation and Service of Solution Delivery Systems and Reverse
Osmosis Systems used in Hemodialysis and Distribution of Filter Products and
Cleaners/Sterilants used in Hemodialysis including Dispensing Equipment.
The design and manufacture of custom hot pressed, high speed grinding wheels.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Masterbox
Secondary
Montebello
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging
Products and Related Machinery and Janitorial Supplies and Turn Key Assembly.
Masterbox
Secondary
Phoenix
AZ
USA
ISO 9001:2008
Redistribution of industrial packaging products including boxes, tapes, film, strapping, sanitary
and janitorial supplies, cushioning material, jiffy bags, stretch film, mailing tubes and kraft
paper.
Single
Sutton
MA
USA
ISO 9001:2008
The manufacture of heavy gauge thermo-formed and vacuum-formed plastic parts for a
variety of industries; including medical.
Primary
Turners Falls
MA
USA
ISO 9001:2008
Design, Manufacture and Distribution of hand tools.
MB MediPrint Ltd
Single
Co Sligo
Ireland
EN ISO 13485:2012
The provision of printing, packaging and related services for the medical industry.ISO9k: The
provision of printing, assembly, packaging and related services to the medical and associated
industries
MC3, Inc.
Single
Ann Arbor
MI
USA
ISO 13485:2003
ISO 13485 Scope: Contract manufacturing of electro-mechanical devices for patient
simulation and healthcare training systems.ISO9K Scope: Contract manufacturing of electromechanical products, components, and assemblies.
McAfee Inc.
Single
Santa Clara
CA
USA
ISO 9001:2008
Provide database support for Consumer, Mobile and Small Business Database Operations.
McConnell Orthopedic Manufacturing Compa
Single
Greenville
TX
USA
EN ISO 13485:2012
The Manufacture and Distribution of Non-Sterile Patient Positioning and Support Devices and
Related Sterile Disposable Support Wraps.
ISO 13485: The Manufacture and Distribution of Healthcare Software and Web-based
Programmes used for Patient Monitoring, Diagnostic and Image Management. The Printing
and Duplication of Healthcare Documentation, including Instructions for Use.ISO 9k: The
Manufacture and Distribution of Healthcare Softeware and the printing and duplication of
Healthcare and other documentation
COMPANY
Mayfield Plastics, Inc.
Mayhew Tools
Scope
McKesson Ireland
Single
Co Cork
Ireland
EN ISO 13485:2012
McKesson Ireland
Single
Co Cork
Ireland
ISO 9001:2008
The Manufacture and Distribution of Healthcare Softeware and the printing and duplication of
Healthcare and other documentation
MDI Medical Ltd.
Secondary
Belfast
Nothern Ireland
EN ISO 13485:2012
The supply, installation, maintenance, service and repair of medical instruments, systems and
equipment.
MDI Medical Ltd.
Primary
Co. Meath
Ireland
EN ISO 13485:2012
The supply, installation, maintenance, service and repair of medical instruments, systems and
equipment.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Kells
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Measurement Specialties, Inc.
Single
Shrewsbury
MA
USA
ISO 9001:2008
The design, sales and service of temperature sensors and probe assemblies used to measure
temperature.
Medentech
Single
Wexford,
Ireland
EN ISO 13485:2012
The manufacture and distribution of disinfection agents specifically intended for disinfecting
medical devices.ISO9k: The design, development, manufacturer and packing of effervesent
tablets and granuals, and the design, development and assembly of water disinfection devices
Medical Device and Implants LLC
Single
Lancaster
PA
USA
I.S.EN ISO13485:2003
Medical Predictive Science Corporation
Single
Charlottesville
VA
USA
ISO 13485/CMDCAS
Medifill Ltd.
Single
Dublin 15
Ireland
ISO 9001:2008
Medivance Inc.
Single
Louisville
USA
ISO 13485/CMDCAS
The Design, Manufacture, Servicing and Distribution of Non-Sterile Devices for Therapeutic
Temperature Management.
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope
Reprocessing Equipment Including Leak Tester Accessories, Sterilants and High Level
Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers,
Hemofilters and Hemoconcentrators and Service of Endoscopic Irrigation Pumps and
Insufflators. Provision of hydrogen peroxide/peracetic acid contract processing services
inaccordance with ISO 14937:2009.
Medivators Inc.
Secondary
Minneapolis
CO
MN
USA
The Manufacturing of Metal and Plastic Medical and Dental Implants, Appliances and Tools.
The design, manufacture and distribution of automated systems for the monitoring and
evaluation of neonatal and paediatric heart rate variability.
The Manafacture and Supply of Bulk Adhesives
Medivators Inc.
Secondary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope
Reprocessing Equipment Including Leak Tester Accessories, Sterilants and High Level
Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers,
Hemofilters and Hemoconcentrators and Service of Endoscopic Irrigation Pumps and
Insufflators. Provision of hydrogen peroxide/peracetic acid contract processing services
inaccordance with ISO 14937:2009.
Medivators Inc.
Secondary
Conroe
TX
USA
ISO 13485/CMDCAS
Design and Development, Manufacture, and Distribution of Endoscopic Irrigation Pumps and
Insufflators, Disposable Valves, Sterile Tubing Sets and Accessories for Endoscopy and
General Surgery.
Medivators Inc.
Secondary
Conroe
TX
USA
ISO 13485/CMDCAS
Design and Development, Manufacture, and Distribution of Endoscopic Irrigation Pumps and
Insufflators, Disposable Valves, Sterile Tubing Sets and Accessories for Endoscopy and
General Surgery.
Medivators Inc.
Primary
Conroe
TX
USA
ISO 13485/CMDCAS
Design and Development, Manufacture, and Distribution of Endoscopic Irrigation Pumps and
Insufflators, Disposable Valves, Sterile Tubing Sets and Accessories for Endoscopy and
General Surgery.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Primary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope
Reprocessing Equipment Including Leak Tester Accessories, Sterilants and High Level
Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers,
Hemofilters and Hemoconcentrators and Service of Endoscopic Irrigation Pumps and
Insufflators. Provision of hydrogen peroxide/peracetic acid contract processing services
inaccordance with ISO 14937:2009.
Medspira LLC
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
The design, manufacture, and distribution of active manometry systems and catheters,
magnetic resonance imaging accessories, and patient biofeedback monitors.
Medtronic
Single
Co. Galway
Ireland
OHSAS 18001:2007
The design and manufacture of medical devices.
Medtronic
Single
Co. Galway
Ireland
OHSAS 18001:2007
The environmental aspects for the design and manufacture of Cardiology Products
Medtronic 3F Therapeutics, Inc.
Primary
Santa Ana
CA
USA
I.S.EN ISO13485:2012
The design, manufacture, and distribution of percutaneous transcatheter aortic valve
bioprostheses, and related delivery systems.
Medtronic 3F Therapeutics, Inc.
Secondary
Santa Ana
CA
USA
I.S.EN ISO13485:2012
The design, manufacture, and distribution of percutaneous transcatheter aortic valve
bioprostheses, and related delivery systems.
Medtronic Ablation Frontiers LLC
Single
Carlsbad
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture and Distribution of RF Ablation Systems,
including Sterile Disposable Catheters, Sheaths and Guidewires, and the Service of RF
Ablation Instruments.
USA
ISO 13485/CMDCAS
MD Scope: The design, manufacture and distribution of percutaneous tissue aortic valve,
delivery system, compression loading device and guide wires for use in cardiovascular
diagnostic and interventional procedures.CMDCAS Scope: The design, manufacture and
distribution of percutaneous tissue aortic valve, delivery system, compression loading device
and guide wires for use in cardiovascular diagnostic and interventional procedures.
Canada
ISO 13485/CMDCAS
The Design and Development, Manufacture and Distribution of RF Ablation Systems,
including Sterile Disposable Catheters, Sheaths and Guidewires and the Service of RF
Ablation Instruments.
ISO 13485/CMDCAS
MD Scope: The design, manufacture and distribution of percutaneous tissue aortic valve,
delivery system, compression loading device and guide wires for use in cardiovascular
diagnostic and interventional procedures.CMDCAS Scope: The design, manufacture and
distribution of percutaneous tissue aortic valve, delivery system, compression loading device
and guide wires for use in cardiovascular diagnostic and interventional procedures.
ISO 13485/CMDCAS
MD Scope: The design, manufacture and distribution of percutaneous tissue aortic valve,
delivery system, compression loading device and guide wires for use in cardiovascular
diagnostic and interventional procedures.CMDCAS Scope: The design, manufacture and
distribution of percutaneous tissue aortic valve, delivery system, compression loading device
and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medivators Inc.
Medtronic CoreValve LLC
Medtronic CryoCath LP
Medtronic Mexico S. de R.L. de CV
Medtronic Mexico S. de R.L. de CV
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Primary
Santa Ana
Secondary
Pointe-Claire, Quebec
Secondary
Secondary
Baja California
Baja California
CA
Mexico
Mexico
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
Medtronic Mexico S. de R.L. de CV
Secondary
Baja California
Medtronic, Inc.
Secondary
Carlsbad
Medtronic, Inc.
Secondary
Medtronic, Inc.
COMPANY
Country
Scheme
Mexico
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems,
including Sterile Disposable Catheters, Sheaths and Guidewires and the Service of RF
Ablation Instruments.
CA
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems,
including Sterile Disposable Catheters, Sheaths and Guidewires and the Service of RF
Ablation Instruments.
Mounds View
CA
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems,
including Sterile Disposable Catheters, Sheaths and Guidewires and the Service of RF
Ablation Instruments.
Primary
Minneapolis
MN
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems,
including Sterile Disposable Catheters, Sheaths and Guidewires and the Service of RF
Ablation Instruments.
Megadyne Medical Products Inc.
Single
Draper
UT
USA
ISO 13485/CMDCAS
Mergon
Single
Co. Westmeath
Ireland
ISO 9001:2008
Mergon International
Single
Co. Westmeath
Ireland
EN ISO 13485:2012
The manufacture of blow moulded components and component assembles for the medical
device industry.
MGS Manufacturing Group LTD
Single
Co. Kildare
Ireland
ISO 13485:2003
Contract Moulding and Manufacture of components for the Medical Device Industry.ISO9K:
Contract Moulding of injection molded components and mould tool maintence and repaire
Microfabrica, Inc.
Single
Van Nuys
CA
USA
ISO 13485:2003
MD 13485 only: Manufacture and distribution of miniature metal medical device parts and
components.ISO 9001 only: Manufacture and distribution of miniature metal parts and
components.
MicroLan Systems, Inc.
Single
Merrimack
NH
USA
ISO 9001:2008
The configuration and production of custom industrial computer systems.
Microsemi Ireland
Single
Co Clare
Ireland
AS 9100 - C
Screening and Supply of High Reliability Discrete Semiconductor Component.
Microsemi Ireland
Single
Co Clare
Ireland
ISO 14001:2004
Screening and Supply of High Reliability Discrete Semiconductor Component.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The design, manufacture, distribution and service of sterile and non-sterile medical devices
for electrosurgical use.
The technical moulding and assembly of automotive, medical and industrial products.
4/10/2015
Profile
Type
CITY
Microsoft Operations Puerto Rico, LLC
Single
Humacao
Microteq Engineering, Inc.
Single
San Antonio
Microwave Components and Systems Inc.
Single
Mid-State Machine Products
Mid-State Machine Products
COMPANY
Country
Scheme
Puerto Rico
ISO 9001:2008
Manufacture of Optical Media CD/DVD ROM.
TX
USA
ISO 9001:2008
Manufacturing Facility providing Precision Machining, Sheet Metal, Fabrication, Wire Harness,
Welding, Painting and Electrical/Mechanical Assemblies for Department of Defense,
Aerospace, Energy, Semiconductor and Oil Industry.
Northborough
MA
USA
ISO 9001:2008
Design and Manufacture of Microwave Components.
Primary
Winslow
ME
USA
AS 9100 - C
Provider of machined products and related services (e.g. weld and NDE) to a customer design
and specified requirement.
Secondary
Waterville
ME
USA
AS 9100 - C
Provider of machined products and related services (e.g. weld and NDE) to a customer design
and specified requirement.
Midwest Truck & Auto Parts, Inc.
Single
Chicago
IL
USA
ISO 9001:2008
Wholesale Supplier of Aftermarket Truck and Automotive Components and Fabricated
Assemblies
Mile Hi Foods
Single
Denver
CO
USA
ISO 14001:2004
Distribution of food
Miramar Labs, Inc.
Single
Santa Clara
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution and Servicing of Microwave Energy Generation
Systems, Electro-Mechanical Applicators, and related Sterile Accessories for the treatment of
Dermatologic Disorders.
Modified Polymer Components Inc.
Primary
Sunnyvale
CA
USA
EN ISO 13485:2012
Design, Development, and Manufacturing of Polymer Based Components for Medical Device
and Diagnostic Applications.ISO 9001:2008 Scope: Design, Development, and Manufacturing
of Polymer Based Components for Industrial Applications
Modified Polymer Components Inc.
Secondary
Sunnyvale
CA
USA
ISO 9001:2008
Design, Development, and Manufacturing of Polymer Based Components for Industrial
Applications.
USA
ISO 13485:2003
9K Scope: Contract Design, Prototyping Manufacture and Service of General Commercial
Electronic Devices and Electronic Sub-Assemblies for Medical Devices.ISO 13485 Scope:
Contract Design, Development and Manufacturing of Implantable and Non-Implantable
Medical Devices and Related components and Subsystems.
Ireland
EN ISO 13485:2012
Modulus Inc.
Single
San Jose
Moll Industries Ireland Ltd
Single
Co. Donegal
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
CA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The manufacture, assembly and packaging of injection molded medical device components.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Monobind Inc.
Secondary
Lake Forest
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Medical Device
Immunoassays, and Related Reagent Products and Equipment
Monobind Inc.
Primary
Lake Forest
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Medical Device
Immunoassays, and Related Reagent Products and Equipment
Monzite d.b.a. Impellimax
Single
Nashua
NH
USA
ISO 9001:2008
Mound Laser & Photonics Center, Inc.
Single
Kettering
OH
USA
EN ISO 13485:2012
The Manufacture, Laser MicroMachining, Laser Microcutting, Laser Welding, Laser Marking
and Surface Finishing of Components and Subassemblies for the Medical Device Industry.
Moximed, Inc.
Single
Hayward
CA
USA
EN ISO 13485:2012
The design, manufacture and distribution of non-active orthopaedic implants and related
instrumentation for knee osteoarthritis.
MuShield Company Inc
Single
Londonderry
NH
USA
ISO 9001:2008
The manufacture of sheet metal components with magnetic shielding properties.
Myers Controlled Power, LLC
Single
North Canton
OH
USA
ISO 9001:2008
Design, Manufacture, and Servicing of AC & DC Electrical Switchgear and Switchboards,
Circuit Breakers, Bus Duct, Relay Panels, Power Control Centers, Metered Service Pedestals,
Panel Boards, Battery Analysis, Enclosures, Rectifiers, Inverters, andRelated Equipment.
Nash Manufacturing and Grinding Services
Single
Springfield
MA
USA
ISO 9001:2008
The design, manufacture and sales of precision machined components to customer
requirements.
Primary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Danville
Secondary
Danville
KY
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Fordsville
Secondary
Fordsville
KY
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Jasper 11th Av
Secondary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
COMPANY
National Office Furniture
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Design and Manufacture of Microelectronic Assemblies.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Secondary
Santa Claus
IN
USA
ISO 9001:2008
Nelipak Holdings Ireland Ltd
Single
Galway
Ireland
EN ISO 13485:2012
Neo-Shiny Industrial Corporation
Single
Taoyuan Hsien, 333
Taiwan, R.O.C.
ISO 9001:2008
Neo-Shiny Industrial Corporation
Single
Taoyuan Hsien
Taiwan, R.O.C.
ECCB Manufacture App
neoSurgical Ltd
Primary
Galway
Ireland
EN ISO 13485:2012
The Design, Manufacture and Distribution of Suture-based Anchor Systems for Closure of
Port site Defects during Edoscopic/Laproscopic Surgery.
neoSurgical Ltd
Secondary
Dublin
Ireland
EN ISO 13485:2012
The Design, Manufacture and Distribution of Suture-based Anchor Systems for Closure of
Port site Defects during Edoscopic/Laproscopic Surgery.
NeoTract, Inc.
Single
Pleasanton
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Implantable Medical Devices and Related
Procedure Accessories in the area of Urology.
Netco Extruded Plastics, Inc.
Single
Hudson
MA
USA
ISO 9001:2008
Neurovision Medical Products, Inc.
Single
Ventura
CA
USA
ISO 13485/CMDCAS
Nikkiso Cryo Incorporated
Single
North Las Vegas
NV
USA
ISO 9001:2008
Nobert Plating Co.
Primary
Chicago
IL
USA
AS 9100 - C
The provision of Electroless, Electroplating and Metal Finishing Services.
Nobert Plating Co.
Secondary
Chicago
IL
USA
AS 9100 - C
The provision of Electroless, Electroplating and Metal Finishing Services.
COMPANY
National Office Furniture-Santa Claus
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The design, manufacture and sales of office furniture products and sub-assemblies.
MD Scope: Contract Manufacturing, Assembly, and Packaging of Medical DevicesISO9K
Scope: Design, Manufacturing and Supply of Packaging for the Healthcare, Electronic and
Pharmaceutical Industries.
Design, manufacture and sales of Drying, Heat Treatment, Hot Air Ovens and UV Curing
Equipment.
Design, manufacture and sales of drying, heat treatment, hot air ovens and UV curing
equipment
Manufacturer and supplier of plastic extruded components to the commercial and medical
device industries.
The design, manufacture, distribution and service of laryngeal surface electrodes, nerve
location devices and software, surface electrodes, stimulation instruments, and surgical
devices used for nerve monitoring in head and neck surgery.
Sales, Design, Manufacture, Testing, and Service of Pumps.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Secondary
Chicago
IL
USA
AS 9100 - C
Nomax Inc.
Single
St. Louis
MO
USA
EN ISO 13485:2012
Norben Company, Inc.
Single
Willoughby
OH
USA
ISO 9001:2008
Distributor of Food and Chemical Ingredients for Pharmaceutical, Food/Nutrition and
Electronic Industries.
Norgren Kloehn, Inc.
Single
Las Vegas
NV
USA
ISO 9001:2008
The Design and Manufacture of Fluid Handling Devices.
Primary
Camarillo
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Refurbished X-Ray Tube Assemblies and Image
Intensifiers, and Distribution of X-Ray Tube Assemblies and Image Intensifiers for Medical
Imaging Systems.
Northern Clearing Inc.
Single
Ashland
WI
USA
ISO 14001:2004
The processes related to the management of right-of-way land clearing, reclamation, and site
work (Clearing, Electrical, Dirt and Maintenance)
Northern Clearing Inc.
Single
Ashland
WI
USA
ISO 9001:2008
The processes related to the management of right-of-way land clearing, reclamation, and site
work (Clearing, Electrical, Dirt and Maintenance)
Northern Clearing Inc.
Single
Ashland
WI
USA
OHSAS 18001:2007
The processes related to the management of right-of-way land clearing, reclamation, and site
work (Clearing, Electrical, Dirt and Maintenance)
NovaBay Pharmaceuticals, Inc.
Single
Emeryville
CA
USA
ISO 13485:2003
Design, development, manufacture, and distribution of medical devices for skin and wound
cleansing, and for contact lens cleansing.
Novariant
Single
Fremont
CA
USA
ISO 9001:2008
The Design, Manufacture, Sales and Service of Auto Steering Solutions.
COMPANY
Nobert Plating Co.
North American Imaging
Scope
The provision of Electroless, Electroplating and Metal Finishing Services.
Manufacture and distribution of sterile diagnostic ophthalmic strips.
Nypro
Single
Co. Wicklow
Ireland
EN ISO 13485:2012
MD Scope: The Contract Design and Development, Manufacture, Automated Assembly and
Testing of Injection Moulded Components and Sub-Assemblies.ISO9K Scope: The contract
manufacture, automated assembly and testing of injection moulded components and subassemblies.
Nypro Ltd
Single
Co. Waterford
Ireland
EN ISO 13485:2012
MD & ISO9K Scope: The manufacture and assembly of injection moulded medical device
components.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Obalon Therapeutics, Inc
Single
Carlsbad
CA
USA
EN ISO 13485:2003
Design, Manufacture and Distribution of Gastric Balloon Systems for Weight Loss
Ocean Springs Metal Manufacture Ltd.
Single
Guangdong
China
ECCB HSPM
Manufacture of springs and metal stampings for electrical and electronic products
OMG Borchers sas
Single
Castres
France
OHSAS 18001:2007
Development, production, sale and trade of additives for paints, varnishes, additives,
polyester and printing inks
ON Light Sciences, Inc.
Single
Dublin
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Gel Based Patches for use as Adjunct Therapy
during Laser Removal of Cutaneous Vascular Lesions, Benign Pigmented Lesions, and
Tattoos.
Operational Technologies Corporation
Secondary
San Antonio
TX
USA
TL 9000 R5.5/R5.0
ISO 9001 Scope: Supply Chain Management ServicesTL9000-V Scope: Supply Chain
Management Services TL 9000 R5.5/R5.0 service for the following product Categories: 7.4
Repair Service, 7.7.5.1 Logistical Service, Third Party.
Operational Technologies Corporation
Primary
San Antonio
TX
USA
TL 9000 R5.5/R5.0
ISO 9001 Scope: Supply Chain Management ServicesTL9000-V Scope: Supply Chain
Management Services TL 9000 R5.5/R5.0 service for the following product Categories: 7.4
Repair Service, 7.7.5.1 Logistical Service, Third Party.
Single
Woburn
MA
USA
EN ISO 13485:2012
The design, development, manufacture, and distribution of in-vitro diagnostic devices
including reagents, calibrators, control materials, kits, instruments, and systems for the
determination and evaluation of biomarkers in the areas of oncology andendocrinology.
OpTech Enterprise Solutions
Secondary
Laredo
TX
USA
TL 9000 R5.5/R5.0
TL9000-V Scope: Supply Chain Management Services for the following product categories:
7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain
Management Services
OpTech Enterprise Solutions
Secondary
Yuma
AZ
USA
TL 9000 R5.5/R5.0
TL9000-V Scope: Supply Chain Management Services for the following product categories:
7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain
Management Services
OpTech Enterprise Solutions
Secondary
Sonora C.P.
Mexico
TL 9000 R5.5/R5.0
TL9000-V Scope: Supply Chain Management Services for the following product categories:
7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain
Management Services
OpTech Enterprise Solutions
Secondary
Nuevo Laredo,
Tampaulipas
Mexico
TL 9000 R5.5/R5.0
TL9000-V Scope: Supply Chain Management Services for the following product categories:
7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain
Management Services
Primary
San Antonio
USA
TL 9000 R5.5/R5.0
TL9000-V Scope: Supply Chain Management Services for the following product categories:
7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain
Management Services
COMPANY
OPKO Diagnostics LLC
OpTech Enterprise Solutions, LLC
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
TX
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
OptiScan Biomedical Corporation
Single
Hayward
CA
USA
ISO 13485/CMDCAS
Ortho Development Corporation
Single
Draper
UT
USA
ISO 13485:2003
Ovelle Ltd
Single
Dundalk
Ireland
EN ISO 13485:2012
Owens & Minor Distribution, Inc.
Secondary
Redlands
CA
USA
I.S.EN ISO13485:2012
ISO 13485 scope: Distribution, Logistics Repackaging and Relabeling for Medical Device
Companies.ISO 9001 scope: Distribution, Logistics Repackaging and Relabeling for Medical
Device and Life Science Companies.
Owens & Minor Distribution, Inc.
Single
Louisville
KY
USA
I.S.EN ISO13485:2012
ISO 13485 scope: Distribution, Logistics Repackaging and Relabeling for Medical Device
Companies.ISO 9001 scope: Distribution, Logistics Repackaging and Relabeling for Medical
Device and Life Science Companies.
Pantronix Corporation
Single
Fremont
CA
USA
ISO 13485:2003
The assembly, packaging and reliability testing of semiconductor devices, printed circuit
boards and electronic systems for medical devices.ISO 9k: The assembly, packaging and
reliability testing of semiconductor devices, printed circuit boards and electronic systems.
Parametric Technology
Secondary
Esslingen
Germany
ISO 9001:2008
The development and delivery of Technical Support for PTC software products.
Parametric Technology (UK) Ltd.
Secondary
Farnborough
United Kingdom
ISO 9001:2008
The development and delivery of technical support for PTC software products.
Parametric Technology Corp (Shanghai)
Secondary
Shanghai
China
ISO 9001:2008
The development and delivery of technical support for PTC software products.
Parametric Technology GmbH
Secondary
Unterschleissheim
Germany
ISO 9001:2008
The development and delivery of technical support for PTC software products.
Parametric Technology GmbH -Sindelfingen
Secondary
Germany
ISO 9001:2008
The development and delivery of technical support for PTC software products.
Parametric Technology SA
Secondary
France
ISO 9001:2008
The development and delivery of technical support for PTC software products.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Aix-en-Provence, Cedex
03
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Design, Manufacturing and Distribution of Non-Implantable Blood Glucose Monitoring
Systems and Related Accessories.
The Design, Manufacture, and Distribution of Orthopaedic Implants in the area of Knee, Hip,
Trauma and Spinal Reconstruction.
Design, manufacture and distribution of non-medicated skin creams and the contract
manufacture of non-medicated skin creams.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Paricon Technologies Corporation
Single
Taunton
MA
USA
ISO 9001:2008
Passy-Muir, Inc.
Single
Irvine
CA
USA
ISO 13485/CMDCAS
PCCW Global
Single
Herndon
VA
USA
ISO 9001:2008
Maintenance and Operations for a Global International Broadband Data and IP services, and
Customized Network Services.
Pega Precision Inc.
Single
Morgan Hill
CA
USA
ISO 9001:2008
Precision sheet metal and machining job shop specializing in prototype and production.
Peninsula Metal Fabrication
Single
San Jose
CA
USA
ISO 9001:2008
Manufacturing of Precision Sheet Metal Products and Specializing in Tubular Metal Frames.
Pentair Valves and Controls
Single
Reno
NV
USA
ISO 9001:2008
The design, manufacture and service of knife-gate and control valves.
Penumbra, Inc.
Single
Alameda
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Endovascular Implants for the treatment of
aneurysms, Catheters, Guidewires, Introducer Sheaths and related accessories for
Neurological and Peripheral intravascular access,diagnosis, and treatment. The Design,
Manufacture, Distribution and Service of Active Aspiration Systems and related accessories.
Percutaneous Systems, Inc.
Single
Palo Alto
CA
USA
ISO 13485/CMDCAS
The design, manufacturing and distribution of urological catheters and stents.
COMPANY
Scope
Design and manufacture of high performance separable interconnection products.
The design, manufacture and distribution of tracheostomy and ventilator swallowing and
speaking valves.
PerkinElmer
Secondary
North Billerica
MA
USA
ISO 14001:2004
Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled
Analogues, Radionuclides, Microspheres, Diagnostic and Research Detection Systems (Kits)
and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kitand
Reagents
PerkinElmer
Secondary
North Billerica
MA
USA
ISO 9001:2008
Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled
Analogues, Radionuclides, Microspheres, Diagnostic and Research Detection Systems (Kits)
and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kitand
Reagents
PerkinElmer
Primary
Shelton
CT
USA
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Chromatographic Time of Flight Mass
Spectrometer Instrument, Components, Related Software and Peripherals.
PerkinElmer
Single
Shelton
CT
USA
ISO 9001:2008
The design, development, manufacture and service of analytical instruments and systems,
including associated software.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
PerkinElmer
Single
Shelton
CT
USA
ISO 14001:2004
The Design, Development, Manufacture and Service of Analytical Instruments and Systems,
including Associate Hardware and Consumables.
PerkinElmer
Single
Shelton
CT
USA
OHSAS 18001:2007
The Design, Development, Manufacture and Service of Analytical Instruments and Systems,
including Associated Software and Consumables.
PerkinElmer
Secondary
Billerica
MA
USA
OHSAS 18001:2007
Design, manufacture and distribution of radiolabeled specialty chemicals, non-labeled
analogues, radionuclies, microspheres, diagnostic and research detection systems (kits)and
reagents, molecular biology kits and reagents, and custom membranes kits and reagents.
PerkinElmer
Secondary
Branford
CT
USA
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Chromatographic Time of Flight Mass
Spectrometer Instrument, Components, Related Software and Peripherals.
Single
Roissy CDG Cedex
France
ISO 9001:2008
Development of Qualification service of laboratory instrumentation-Conception, development,
production and calibration of measuring systems and laboratory equipment.
PerkinElmer - LAS
Primary
Boston
USA
OHSAS 18001:2007
Design, manufacture and distribution of radiolabeled specialty chemicals, non-labeled
analogues, radionuclies, microspheres, diagnostic and research detection systems (kits)and
reagents, molecular biology kits and reagents, and custom membranes kits and reagents.
PerkinElmer (India) Pvt Ltd
Primary
Maharashtra
India
ISO 9001:2008
The Sales and Service of Analytical Instrumentation and Systems, Consumables and related
after-sales support
PerkinElmer (India) Pvt Ltd
Secondary
Andhra Pradesh – 500
081
India
ISO 9001:2008
The Sales and Service of Analytical Instrumentation and Systems, Consumables and related
after-sales support
PerkinElmer (Schweiz) AG
Single
Switzerland
ISO 9001:2008
Sale, Support and Service of PerkinElmer and OEM Instruments which are being used in
Chemical and Biological Laboratories.
PerkinElmer Health Sciences B.V.
Single
TH Groningen
The Netherlands
ISO 14001:2004
Development, Production and Distribution of Reagents and Supplies for Applications in
Industrial, Biomedical and Pharmaceutical Industries.
PerkinElmer Health Sciences B.V.
Single
TH Groningen
The Netherlands
OHSAS 18001:2007
Development, Production and Distribution of Reagents and Supplies for Applications in
Industrial, Biomedical and Pharmaceutical Industries.
PerkinElmer Health Sciences B.V.
Single
TH Groningen
The Netherlands
ISO 9001:2008
Development, Production and Distribution of Reagents and Supplies for Applications in
Industrial, Biomedical and Pharmaceutical Industries.
COMPANY
PerkinElmer - LabMetrix Division
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
PerkinElmer Health Sciences, Inc.
Single
Greenville
SC
USA
I.S.EN ISO13485:2012
PerkinElmer Holdings Inc.
Single
Santa Clara
CA
USA
ISO 14001:2004
The Design, Manufacture, Distribution and Service of X-Ray Detector Panels and X-Ray
Detectorsused in Industrial and Medical Digital Imaging.
PerkinElmer Holdings Inc.,
Single
Santa Clara
CA
USA
OHSAS 18001:2007
The Design, Manufacture, Distribution and Service of X-Ray Detector Panels and X-Ray
Detectors used in Industrial and Medical Digital Imaging Applications.
COMPANY
Scope
Design, manufacture and supply of specialized filter paper devices
PerkinElmer Inc.
Primary
Boston
MA
USA
ISO 14001:2004
Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled
Analogues, Radionuclides, Microspheres, Diagnostic and Research Detection Systems (Kits)
and Reagents, Molecular Biology Kits and Reagents, andCustom Membranes Kits and
Reagents.
PerkinElmer Inc.
Primary
Santa Clara
CA
USA
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Panels and Detectors for X-Ray Imaging
Applications.
PerkinElmer Inc.
Primary
Boston
MA
USA
ISO 9001:2008
The Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues,
Radionuclides, Microspheres, Diagnostic and Research Detection Systems (kits) and
Reagents, Molecular Biology Kits and Reagents,and Custom Membranes, Kits and Reagents
as well as Assay Development and Compound Screening Services.
PerkinElmer Ireland Ltd
Single
Dublin
Ireland
ISO 9001:2008
Supply, Service and Support of Laboratory Equipment.
PerkinElmer Italia S.p.A.
Single
Milano
Italy
ISO 9001:2008
Trading, installation, service assistance, application support and training for laboratory
instrumentation for R&D and analytical controls.Trading of related accessories and
consumable products.
PerkinElmer LAS (Germany) GmbH
Single
Germany
ISO 9001:2008
The Sales and Service of Analytical Instrumentation, Including Consumables and the
Provision of Technical Education.
PerkinElmer Llantrisant
Single
Llantrisant
United Kingdom
ISO 9001:2008
The manufacture of analytical instruments and systems.
PerkinElmer Llantrisant
Single
Llantrisant
United Kingdom
ISO 14001:2004
The manufacture of analytical instruments and systems.
PerkinElmer Llantrisant
Single
Llantrisant
United Kingdom
OHSAS 18001:2007
The manufacture of analytical instruments and systems.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
PerkinElmer Ltd.
Single
PerkinElmer SAS
Secondary
COMPANY
PerkinElmer SAS
Primary
STATE
Country
Scheme
Beaconsfield
United Kingdom
ISO 9001:2008
The design, development, installation and servicing of analytical instruments and systems
including OneSource multi-vendor services.
Villepinte
France
ISO 9001:2008
Marketing and sales of scientific equipment, accessories and consumables for the research,
industry, health and environmental sectors.Service provider for maintenance, training and
other related services.
France
ISO 9001:2008
Marketing and sales of scientific equipment, accessories and consumables for the research,
industry, health and environmental sectors. Service provider for maintenance, qualification,
training and other related services.Commercialisation d’équipements scientifiques,
d’accessoires et de consommables pour les secteurs de la recherche, de l’industrie, de la
santé et de l’environnement. Réalisation de prestations de maintenance, de qualification, de
formation et deservices associés.
Villebon SUR YVETTE
Scope
PerkinElmer Shared Services sp. z.o.o.
Single
Poland
ISO 9001:2008
The provision of order entry, receipt and processing of customer orders, service calls.
PERKINELMER SINGAPORE PTE LTD
Single
Singapore
ISO 14001:2004
Research and Development, and Manufacture of Analytical Science Instruments. Manufacture
of Life Science Technology Instruments.
PERKINELMER SINGAPORE PTE LTD
Single
Singapore
OHSAS 18001:2007
Research and Development, and Manufacture of Analytical Science Instruments. Manufacture
of Life Science Technology Instruments.
PerkinElmer Singapore Pte. Ltd.
Single
Singapore
EN ISO 13485:2012
ISO13485: The Design, Development and Manufacture of Atomic Spectroscopy, Plate Reader
and Gamma Counting Instruments and Systems for Clinical Applications and/or In Vitro
Diagnostic use.ISO9K: The design, development and manufacture of analytical and detection
systems
Secondary
Walluf
Germany
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Panels and Detectors for X-Ray Imaging
Applications.
Phardiag Ltd
Single
Co. Clare
Ireland
EN ISO 13485:2012
The forecasting, procurement, and distribution of pharmaceutical and in-vitro diagnostic
products, and also secondary packaging of IVD products on behalf of third parties.
PHOTONIS USA
Single
Sturbridge
MA
USA
ISO 9001:2008
The design, manufacturing, testing and sales of microchannel plates, electron multipliers,
detectors and associated electronics for analytical instruments, ion guides, electron sources,
fiber optic light guides and specialty glass products.
PHOTONIS USA, Pennsylvania, Inc.
Single
Lancaster
PA
USA
ISO 9001:2008
The Design and Manufacture of Electron Tubes.
Piconics, Incorporated
Single
Tyngsboro
MA
USA
ISO 9001:2008
Manufacture and sales of custom and standard passive microelectronic components for the
RF, Telecommunications, medical, military and commercial markets.
PerkinElmer Technologies GmbH & Co. KG
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Stafford
TX
USA
ISO 13485/CMDCAS
Secondary
Uxbridge
MA
USA
AS 9100 - C
The fabrication and assembly of sheet metal components and assemblies, including welding
and powdercoating.
Precision Engineering Inc.
Primary
Uxbridge
MA
USA
AS 9100 - C
The fabrication and assembly of sheet metal components and assemblies, including welding
and powdercoating.
Precision Engineering Inc.
Single
Uxbridge
MA
USA
ISO 14001:2004
The fabrication and assembly of sheet metal components and assemblies, including welding
and powdercoating.
Precision Rings Incorporated
Single
Indianapolis
IN
USA
AS 9100 - C
Precision Swiss Products, Inc.
Single
Milpitas
CA
USA
EN ISO 13485:2012
Precision Swiss Products, Inc.
Single
Milpitas
CA
USA
AS 9100 - C
President Titanium Co., Inc.
Single
Hanson
MA
USA
ISO 9001:2008
The distributor of domestic-made 6AL/4V Grade 5, 6AL/4V ELI and CP-Grade 4, titanium bar,
sheet and plate serving the aerospace and medical industries.
Pressco Ltd
Single
Dublin 11
Ireland
EN ISO 13485:2012
The contract manufacture for the assembly and test of respiratory and diagnostic devices.ISO
9k - The design manufacture, assembly and test of precision machined products.
Primary Flow Signal, Inc.
Single
Cranston
RI
USA
ISO 9001:2008
The design and manufacturing of flow measuring equipment.
ProComm Inc. of Hoopeston IL
Single
Onarga
IL
USA
ISO 9001:2008
Assembly of CB Antennas and accessories.
Professional Machine LLC
Single
Bellingham
MA
USA
ISO 9001:2008
The production of precision CNC machined parts from engineering prototypes to large
production runs for medical, aerospace, construction and energy industries.
COMPANY
Portable Therapeutix, LLC
Precision Engineering
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Manufacture and Distribution of active medical devices used for cold compression
therapies.
Design and manufacture of piston and seal rings.
Contract manufacturing of non-sterile components and subassemblies for medical products.
9K Scope: Contract manufacturing of non-sterile components and subassemblies for
aerospace and medical productsAS Scope: Contract manufacturing of components and
subassemblies.
4/10/2015
COMPANY
Proxim Wireless Corporation
Profile
Type
CITY
STATE
Country
Scheme
Single
Milpitas
CA
USA
ISO 9001:2008
The design, manufacturing and marketing of wireless networking products.
Scope
PT Excelitas Technologies Batam
Secondary
Indonesia
ISO 9001:2008
Design and Manufacture of Optoelectronics Products.
PT. Excelitas Technologies Batam
Primary
Indonesia
ISO 9001:2008
Design and Manufacture of Optoelectronics Products.
PT. Excelitas Technologies Batam
Primary
Indonesia
ISO 14001:2004
Design and Manufacture of Optoelectronics Products.
PT. Excelitas Technologies Batam
Secondary
Indonesia
ISO 14001:2004
Design and Manufacture of Optoelectronics Products.
PTC Corporation
Secondary
Waterloo
ON
Canada
ISO 9001:2008
The development and delivery of Technical Support for PTC software products.
Primary
Needham
MA
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Inc. - Ann Arbor
Secondary
Ann Arbor
MI
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Inc. - Blaine
Secondary
Blaine
MN
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Inc. - Fort Collins
Secondary
Fort Collins
CO
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Japan - Tokyo
Secondary
Tokyo
Japan
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC software (India) Pvt. Ltd.
Secondary
Pune
India
ISO 9001:2008
The development and delivery of technical support for PTC software products .
PTC Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Pulse Communications, Inc.
Profile
Type
CITY
STATE
Country
Scheme
Scope
Single
Herndon
VA
USA
TL 9000 R5.0/5.0
ISO 9001 Scope:The Design and Manufacture of Telecommunications Equipment.TL9000-H
R5.0 Scope: The Design and Manufacture of Telecommunications Equipment for the
following Hardware Product Categories: 3.2.2.1.2.1 Sonet/SDH Transport Systems, 8.2.3 High
Complexity Electronic Assemblies
Pulse Electronics
Single
San Diego
Qioptiq GmbH
Single
D-35614 Asslar
Qioptiq Ltd
CA
USA
ISO 9001:2008
The Research, Design and Development, Marketing, Sales, Support, Administration and
Assembly of LAN products, Connectors, Broadband products including xDHL, HPN, RF,
Wireless, Telecomm products, Anntennas (for mobile phones, wireless devices,automotive),
Power Products, Switchmode Transformers and Micro Components for the Automotive,
Military & Aerospace Industries.
Germany
ISO 9001:2008
Development and Marketing of Precision Optical Products. Manufacturing of optical
Components including Thin Film Surface Technology. Assembly and Test of opto-mechanical
Devices and Systems
Design, development and manufacture of visual and thermal imaging electro-optical
equipment, and the in-service support, tools and test equipment for these products. Design,
development and manufacture of space vehicle optical components and theapplication of nonspace optical coatings.
Primary
Denbighshire
United Kingdom
ISO 14001:2004
Qioptiq Photonics GmbH & Co. KG
Single
D-85622 Feldkirchen
Germany
EN ISO 13485:2012
Qioptiq Photonics GmbH &Co KG
Secondary
D-37081 Göttingen
Germany
ISO 9001:2008
Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems.
Qioptiq Photonics GmbH &Co KG
Primary
D-85622 Feldkirchen
Germany
ISO 9001:2008
Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems.
Qioptiq Photonics GmbH &Co KG
Secondary
D-94209 Regen
Germany
ISO 9001:2008
Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems.
Qioptiq Photonics Limited
Single
Hamble, Hants
United Kingdom
ISO 9001:2008
The design, manufacture and sale of Fiber Optics, Lasers and Fiber Coupled Laser Systems
for use in precision instrumentation.
Qioptiq Singapore Pte. Ltd.
Single
Singapore
ISO 9001:2008
Design/Development, Production and Servicing of Advanced Military and Commercial Optical
and Electro-Optics Components, Assemblies and Systems.
Qioptiq Singapore Pte. Ltd.
Single
Singapore
ISO 14001:2004
Design, Development, Production and Servicing of Advanced, Military and Commercial
Optical and Electro-Optics Components, Assemblies and Systems.
Qioptiq Space Technology
Secondary
United Kingdom
ISO 14001:2004
Design, development and manufacture of visual and thermal imaging electro-optical
equipment, and the in-service support, tools and test equipment for these products. Design,
development and manufacture of space vehicle optical components and theapplication of nonspace optical coatings.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Rhyl
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Design, Manufacturing and Distribution of Precision Optics and Optical-Mechanical Systems.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Quality Controls, Inc.
Single
Northfield
NH
USA
ISO 9001:2008
RAD Data Communications
Single
Mahwah
NJ
USA
TL 9000 R5.0/5.0
Randolph Products
Single
Chicopee
MA
USA
ISO 9001:2008
Design and manufacture of coatings for the Department of Defense, OEM Industry, Wood
Priming Market, Anti Slip Coatings Market and various other Specialty Industries.
Rapid DTM, Inc.
Single
Amherst
NH
USA
ISO 9001:2008
Provision of Manufacture, Inspection and Reverse Engineering Services for all Mold Types;
Fixtures: Gauges: Prototype Parts and Secondary Castings, Based on Customer
Requirements.
Rapid Machining
Single
Nashua
NH
USA
ISO 9001:2008
Proto and production machined Parts manufactured to customer’s 3D model
Rapid Sheet Metal
Single
Nashua
NH
USA
ISO 9001:2008
Low volume sheet metal parts manufactured to our customers 3D model
Rapid Wire Cable
Single
Nashua
NH
USA
ISO 9001:2008
Low volume custom cable and wire harness manufactured to customer model
RBC Medical Innovations
Secondary
Lenexa
KS
USA
EN ISO 13485:2012
The contract design, manufacture, and servicing of electro-mechanical assemblies and
systems for the medical device industry.
RBC Medical Innovations
Single
Lenexa
KS
USA
EN ISO 13485:2012
The contract design, manufacture, and servicing of electro-mechanical assemblies and
systems for the medical device industry.
RCD Components, Inc.
Single
Manchester
NH
USA
ISO 9001:2008
ReFlow Medical, Inc.
Single
San Clemente
CA
USA
EN ISO 13485:2012
The design, manufacture and distribution of endovascular guide catheters.
Renchel Tool Inc
Single
Putnam
CT
USA
EN ISO 13485:2012
Contract Machining and Manufacturing of Components for the Medical Device Industry.ISO
9001 Scope: Contract CNC Machining.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Design, manufacture and distribution of rotor vales and actuators.
TL9000-V Scope: Distribution, sales & technical support of access products and solutions for
carriers, ISP's, cellular networks, service providers and corporate users for the following
product categories:7.1.1 Installation, 7.4 Repair Services and 7.5.1 Technical Assistance and
Customer Support Centers.
The Design, Manufacture, Test and Supply of Active and Passive Electronic Components and
Assemblies.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Resin Designs, LLC
Single
Woburn
MA
USA
ISO 9001:2008
Design, Development and Manufacture of Adhesive Materials, Preforms and Films used in
Microelectronics and other Industrial Applications.
Resin Designs, LLC
Single
Newark
CA
USA
ISO 9001:2008
Design, Development and Manufacture of Adhesive Material for Electronics and Other
Industrial Applications.
REVA Medical, Inc.
Single
San Diego
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Implantable, Drug-eluting, Polymer, Resorbable
Coronary Stents
RFL Electronics Inc.
Single
Boonton Township
NJ
USA
ISO 9001:2008
The design and manufacture of electronic equipment and components for communication and
relaying products in the electric utilities and transportation markets.
Rigaku Analytical Devices
Single
Wilmington
MA
USA
ISO 9001:2008
Design, Development, Manufacture, and Support of Hardware and Software for Portable
Scientific Instruments.
COMPANY
Scope
Rimini Street Inc.
Primary
Pleasanton
CA
USA
ISO 9001:2008
Global provision of enterprise software support services, including client onboarding; client
account management; product support for vendor delivered and client customized code; fix
development and delivery; and research, development and delivery ofworldwide tax, legal and
regulatory updates.
Rimini Street Inc.
Secondary
Las Vegas
NV
USA
ISO 9001:2008
Global provision of enterprise software support services, including client onboarding; client
account management; product support for vendor delivered and client customized code; fix
development and delivery; and research, development and delivery ofworldwide tax, legal and
regulatory updates.
RITEVE
Secondary
Heredia
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Nicoya, Guanacaste
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Barranca, Puntarenas
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Nueve Millas, Limón
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
RITEVE SYC
RockTenn-Puerto Rico, Inc.
Profile
Type
CITY
STATE
Primary
Country
Scheme
Scope
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
Single
Guaynabo
PR
Puerto Rico
ISO 9001:2008
The design and manufacture of corrugated containers.
RSA, The Security Division of EMC
Primary
Bedford
MA
USA
ISO 9001:2008
Production processes for the fulfillment of software and hardware products to provide
computer and internet security solutions.
RSA, The Security Division of EMC
Secondary
Co. Clare
Ireland
ISO 9001:2008
Production processes for the fulfillment of software and hardware products to provide
computer and internet security solutions.
Ruckus Wireless, Inc.
Single
Sunnyvale
CA
USA
ISO 9001:2008
Design, manufacture, distribution, and service Wi-Fi products and technologies for internet
and wireless LAN systems.
Samsung
Single
Austin
TX
USA
ISO 50001
Samsung Austin Semiconductor
Single
Austin
TX
USA
ISO 14001:2004
Wafer Fabrication and Testing
Samsung Austin Semiconductor
Single
Austin
TX
USA
OHSAS 18001:2007
Wafer Fabrication and Testing
San Francisco Circuits, Inc.
Single
San Mateo
CA
USA
ISO 9001:2008
Provider of value added services including PCB layout, manufacturing and assembly services.
Sauer Compressors USA
Single
Stevensville
MD
USA
ISO 9001:2008
Design, Manufacture and support of high-pressure piston compressors for industrial, offshore
and naval applications.
SCA CHATEAU LA LAGUNE
Single
AQUITAINE
France
ISO 14001:2004
Vine growing, AOC wine making, packaging, storage and shipping
SchaererMedical USA, Inc.
Single
Cincinnati
USA
EN ISO 13485:2012
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
OH
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The energy activities and supporting processes associated with the design, fabrication,
The Manufacture and Distribution of Surgical Tables.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Schivo Precision Ltd. t/a Schivo Group
Single
Waterford
Co.
Waterford
Ireland
EN ISO 13485:2012
Scripps Laboratories
Single
San Diego
CA
USA
ISO 9001:2008
Secondary
Superior
CO
USA
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL International
Primary
Berkshire
United Kingdom
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL International
Secondary
Co. Wicklow
Ireland
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL International Belgium NV
Secondary
30001 Leuven
Belgium
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL Multilingual Services GmbH & Co. Kg
Secondary
Stuttgart
Germany
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
Single
Herndon
VA
USA
ISO 9001:2008
Design, implementation, and management of IP (internet protocol) satellite network services.
Primary
Reno
NV
USA
ISO 9001:2008
The design, manufacture and marketing of electronic controls, sensors, thermal control
devices, control knobs, heaters and related products.
Sensing Systems Corporation
Single
New Bedford
MA
USA
ISO 9001:2008
Design and manufacture a full range of measurement products and provide measurement
services to various industries
Sensys Networks, Inc.
Single
Berkeley
CA
USA
ISO 9001:2008
Design and Manufacture of Wireless Vehicle Detection Systems for the Traffic Industry.
Server Technology, Inc.
Single
Reno
NV
USA
ISO 9001:2008
The design and manufacture of remote power management technology for complex
distributed computer networks.
COMPANY
SDL Flatiron
Segovia, Inc.
Selco Products
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The manufacture, assembly and test of machined parts for use in medical devices.
Process Development, Purification, and Sales of Enzymes, Proteins, Antibodies, and Related
Bio-Chemicals for In-Vitro Clinical Diagnostic and Life Science Industries.
4/10/2015
COMPANY
Sheathing Technologies
Profile
Type
CITY
STATE
Country
Scheme
Scope
Single
Morgan Hill
CA
USA
ISO 13485/CMDCAS
The design and development, manufacturing and distribution of sterile and non-sterile
ultrasound probe covers; sterile procedure kits and gel-filled probe cover, and sterile and nonsterile ultrasound coupling gel.
Environmental and reliability testing for electric and electronic products (by EIA-364,
GMW3172, GR-63-CORE, IEC 60068-2, ISO 4892.3, ISO 9227, ISO 16750, JESD-22, J-STD020D, MIL-STD-202, MIL-STD-810F, PSA B2117130, VW80101, applicable ASTM, GB/Tand
ISTA standards), including Vibration test, Mechanical shock test, Free fall test, High
temperature test, Low temperature test, Temperature cyclic test, Salt spray test, Damp heat
tests, Mating and un-mating force test, Wire bending test, Tensiletest, UV test, Compression
test, Thermal shock test, Abrasion resistance test and Pencil hardness test.
ShenZhen BestJ Testing Co., Ltd
Single
Shenzhen
China
IECQ ITL
Sigurd Microelectronics Corp
Single
Hu-kou Twnshp, HsinChu County
Taiwan, R.O.C.
ECCB HSPM
Silhouette Lift
Single
Irvine
CA
USA
ISO 13485/CMDCAS
Design, manufacture, and distribution of sutures for cosmetic lift procedures.
Silver Bullet Therapeutics
Single
San Jose
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Non-Active, Implantable Bone-Fixation Devices
inclusive of Elemental Silver.
Sisco Corporation
Single
Nashville
IL
USA
ISO 9001:2008
Smithstown Light Engineering
Single
Shannon
Co. Clare
Ireland
EN ISO 13485:2012
Smithstown Light Engineering
Single
Co. Clare
Ireland
ISO 14001:2004
Smooth-Bor Plastics
Primary
Laguna Hills
CA
USA
EN ISO 13485:2012
Design, Manufacture and Distribution of flexible plastic tubing for medical device applications.
Smooth-Bor Plastics
Secondary
Spartanburg
SC
USA
EN ISO 13485:2012
Design, Manufacture and Distribution of flexible plastic tubing for medical device applications.
Single
Bloomfield
CT
USA
EN ISO 13485:2012
The Distribution of Active Surgical, Imaging, Monitoring, and Diagnostic Medical Equipment.
The Refurbishment and Distribution of Active Surgical, Imaging, Monitoring, and Diagnostic
Medical Equipment.
Soma Technology, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
The production testing of integrated circuits in wafer and package form.
The manufacture of corrugated containers.
The manufacture of precision components for the Medical Device IndustryISO9K Scope: The
design and manufacture of Precision Tooling and replacement Parts
The design and manufacture of precision tooling and replacement parts.
4/10/2015
Profile
Type
CITY
SOUTHERN TEXTILE CO., LTD.
Primary
SOUTHERN TEXTILE CO., LTD.
COMPANY
Country
Scheme
Taichung City
Taiwan, R.O.C.
ISO 9001:2008
Manufacturing of OE cotton yarns and OE rayon yarns.
Secondary
Taichung City
Taiwan, R.O.C.
ISO 9001:2008
Manufacturing of OE cotton yarns and OE rayon yarns.
Sparton Beckwood
Single
Plaistow
USA
AS 9100 - C
Spectrum Research & Testing Lab, Inc.
Single
Taoyuan County
Taiwan
IECQ ITL
Spiration, Inc.
Single
Redmond
USA
ISO 13485/CMDCAS
Spirox Corporation
Single
Hsinchu
Taiwan, R.O.C.
ISO 9001:2008
The Verification Services of ESD/Latch-Up (heating by Thermo Stream), SEM, FIB, FA and
RA (Reliability Test Service) with HTOL, BLT, THB, HTSL, HAST, TCT and Preconditioning.
Spirox Corporation
Single
Hsinchu
Taiwan, R.O.C.
IECQ ITL
The Verification Services of ESD/Latch-Up (heating by Thermo Stream), SEM, FIB, FA and
RA (Reliability Test Service) with HTOL, BLT, THB, HTSL, HAST, TCT and Preconditioning.
Sponge-Jet, Inc.
Primary
Newington
NH
USA
ISO 9001:2008
The Design, Manufacture, Service, and Distribution of Abrasive Media and Surface
Preparation Equipment.
Sponge-Jet, Inc.
Secondary
Montrose
PA
USA
ISO 9001:2008
The Design, Manufacture, Service, and Distribution of Abrasive Media and Surface
Preparation Equipment.
Stamping Technologies, Inc.
Single
Laconia
NH
USA
ISO 9001:2008
The Manufacture of Stamped, Cold Formed, Coined and CNC Machined Metal Parts.
Standex de México S.A. de C.V.
Single
Nogales, Sonora
México
ISO 9001:2008
The Manufacture of Rotary Vane Pumps.
STENTYS S.A.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Primary
Paris
STATE
NH
WA
France
I.S.EN ISO13485:2012
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Contract Manufacturer of Electro-Mechanical Assemblies for the Military, Aerospace,
Semiconductor, Analytical Instrumentation and Automotive Markets.
Reliability testing of IT products, IT Peripherals, RF products, Audio / Video and related
products.
Design, development, manufacture and distribution of bronchoscopic devices, delivery
catheters, and related accessories for biopsy, lung volume reduction, and the treatment of
damaged and/or diseased lung.
The design, manufacture and distribution of implantable bare-metal and drug-eluding
cardiovascular stents and related delivery systems, embolectomy/thrombectomy catherters
and dialation catheters.ISO9k:The design, manufacture and distribution of, implantable baremetal and drug-eluding cardiovascular stents and related delivery systems,
embolectomy/thrombectomy catherters and dialation catheters.
4/10/2015
COMPANY
STENTYS S.A.
Profile
Type
CITY
Secondary
Princeton
SteriPack Limited
Single
Co. Offaly
SteriPack USA (Limited) LLC
Single
Lakeland
Stratus Technologies
Single
Dublin 15
STATE
NJ
FL
Country
Scheme
Scope
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of implantable bare-metal and drug-eluding
cardiovascular stents and related delivery systems.ISO9k:The design, manufacture and
distribution of implantable bare-metal and drug-eluding cardiovascular stents and related
delivery systems.
Ireland
EN ISO 13485:2012
The manufacture and supply of both sterile and non-sterile packaging producs, contract
packaging and assembley of medical devices for the healthcare industry.
USA
ISO 13485:2003
The Manufacture and Distribution of Healthcare Packaging, Sterilizable Health Care
Packaging, and the Contract Assembly and Packaging of Medical Devices.
Ireland
ISO 9001:2008
The worldwide assembly, repair, test and logistics of critical on-line computers.
The design and manufacture of environmental monitoring and control systems, providing realtime data collection, telemetry, control and system software to forecast activities in the areas
of hydrology,meterology and water management. Applications and services include: water
supply, flood warning, irrigation control, maximizing hydro-power production, dam safety, tidal,
groundwater and many others.
Sutron Corporation
Single
Sterling
VA
USA
ISO 9001:2008
Suture Ease, Inc.
Single
San Jose
CA
USA
EN ISO 13485:2012
The Design, Manufacture, and Distribution of Non-Active Laparoscopic Suturing Devices.
Symetis SA
Single
Lausanne
Switzerland
EN ISO 13485:2012
The Design, Manufacture and Distribution of Perataneous Tissue Heart Valve Prostheses and
Related Delivery Catheters, Introducers and surgical Instruments
SyncroPhi Systems Ltd
Single
Co. Galway
Ireland
EN ISO 13485:2012
The design, manufacture, distribution, installation & service of a wireless ambulatory patient
monitoring system.
Mexico
ISO 13485:2003
The contract manufacture of single-use medical products such as gowns, molded products &
components used in medical devices industry.
Mexico
ISO 13485:2003
The contract manufacture of single-use medical products such as gowns, molded products &
components used in medical devices industry.
Syntech de Baja California
Syntech de Baja California
Syntech International Also dba
Synvasive Technology, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary Tijuana Baja California
Primary
Tijuana Baja California
Single
Irvine
CA
USA
ISO 13485:2003
The design and contract manufacture of sterile and non sterile, single and multi use medical
and industrial products including but not limited to gowns, moulded and electro-mechanical
products and components used in medical devices and industry
Primary
Reno
NV
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Balancing Systems and Prosthetic Implantation
Instruments for Orthopaedic Surgery.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
El Dorado Hills
CA
USA
ISO 13485/CMDCAS
Syscom Tech
Single
Moorestown
NJ
USA
ECCB HSPM
Distribution and contract manufacturing of cable assemblies and wire harnesses, printed
circuit board assemblies, industrial control panels, electronic components and
electromechanical assemblies.
Syscom Tech
Single
Moorestown
NJ
USA
ISO 9001:2008
Distribution and contract manufacturing of cable assemblies and wire harnesses, printed
circuit board assemblies, industrial control panels, electronic components and
electromechanical assemblies.
Systems & Processes Engineering Corp.
Single
Austin
TX
USA
ISO 9001:2008
Design, manufacture and service of electro-mechanical equipment used in defense and
commercial applications.
T.M. Electronics, Inc.
Single
Boylston
MA
USA
ISO 9001:2008
Design, Manufacture, Sales and Service of Leak, Flow and Seal Strength Test
Instrumentation and Accessories.
T/C Distribution
Single
Stratford
CT
USA
ISO 14001:2004
Food Distribution Warehouse Services
T2 Biosystems Inc.
Secondary
Wilmington
MA
USA
EN ISO 13485:2012
The design, manufacture and distribution of In-Vitro Diagnostic Systems, including hardware,
software, and associated reagents and controls for the detection of Candida.
T2 Biosystems Inc.
Secondary
Worcester
MA
USA
EN ISO 13485:2012
The design, manufacture and distribution of In-Vitro Diagnostic Systems, including hardware,
software, and associated reagents and controls for the detection of Candida.
T2 Biosystems Inc.
Primary
Lexington
MA
USA
EN ISO 13485:2012
The design, manufacture and distribution of In-Vitro Diagnostic Systems, including hardware,
software, and associated reagents and controls for the detection of Candida.
Tanury Industries
Single
Lincoln
RI
USA
ISO 9001:2008
The provision of electroplating and precious metal finishing services.
TEK Microsystems, Inc.
Single
Chelmsford
MA
USA
ISO 9001:2008
Designs, manufactures, delivers and services high performance signal acquisition,
generation, processing and recording products for embedded real time computer systems,
including integration of Tekmicro and third party products into turnkeyplatforms and systems.
Teledyne Instruments Leeman Labs
Single
Hudson
NH
USA
ISO 9001:2008
Design, Development, Installation and Service of Analytical Instruments for Spectroscopy and
Elemental Analysis.
COMPANY
Synvasive Technology, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The Design, Manufacture, and Distribution of Surgical Saw Blades and Instruments for
Orthopaedic Surgery.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Teledyne Judson Technologies
Single
Montgomeryville
PA
USA
ISO 9001:2008
Teleflex Medical
Single
Co. Limerick
Ireland
EN ISO 13485:2012
Teleplan International
Primary
Roseville
CA
USA
ISO 14001:2004
Provide screening, repair and logistics services on computer peripheral equipment and
information technology products.
Teleplan International
Primary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and
information technology products.
Teleplan International
Secondary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and
information technology products.
Teleplan International
Secondary
Lincoln
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and
information technology products.
Teleplan International
Secondary
Roseville
CA
USA
ISO 14001:2004
Provide Screening, Repair and Logistics Services on computer Peripheral Equipment and
Information Technology Products.
Teleplan International
Secondary
Lincoln
CA
USA
ISO 14001:2004
Provide Screening, Repair and Logistics Services on Computer Peripheral Equipment and
Information Technology Products.
Primary
Minneapolis
MN
USA
ISO 9001:2008
The Design, Manufacture, Sales & Service of Industrial Indoor & Outdoor Cleaning
Equipment.
Teradyne ATE
Secondary
Heredia
Costa Rica
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test
Equipment from New Product Conception through Mature Production.
Teradyne ATE
Secondary
Agoura Hills
CA
USA
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test
Equipment from New Product Conception through Mature Production.
Teradyne ATE
Primary
North Reading
MA
USA
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test
Equipment from New Product Conception through Mature Production.
COMPANY
Tennant Company
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
The research, design, development, and manufacture of custom and standard high
performance Focal Plane Arrays (FPA’s), Infrared Detectors and Integrated Dewar Cooler
Assemblies (IDCA’s) for the Instrumentation, Military and Space markets.
The design and manufacture of precision tubing, components, sterile percutaneous introducer
kits and catheters for distribution and for OEM Manufacturers.
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Singapore
ISO 9001:2008
USA
AS 9100 - C
China
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test
Equipment from New Product Conception through Mature Production.
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test
Equipment from New Product Conception through Mature Production.
Teradyne ATE
Secondary
Teradyne STG
Single
North Reading
Secondary
Suzhou, Jiangsu
Teradyne, Inc.
Single
Buffalo Grove
IL
USA
ISO 9001:2008
Manufacture and Supply of Automated Test Equipment for the Semiconductor Industry.
Teradyne, Inc.
Single
North Reading
MA
USA
ISO 14001:2004
Process Design, Assembly, Repair and Servicing of Test Equipment from New Product
Conception through Mature Production.
The Carlyle Johnson Machine Co., LLC
Single
Bolton
CT
USA
ISO 9001:2008
The Design and Manufacture of Electromagnetic, Mechanical, Air and Hydraulic Clutches and
Brakes, and Related Devices.
The Columbia Group
Single
Panama City Beach
FL
USA
ISO 9001:2008
Design, Fabrication and Testing of Military Systems, Ocean Submersibles, Remote Operated
Vehicles and Related Equipment
The Henry Perkins Company
Single
Bridgewater
MA
USA
ISO 9001:2008
The Manufacture of Gray, Ductile and Wear-resistant Iron Castings.
The Seaberg Company, Inc.
Single
Wilsonville
OR
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Orthopaedic Appliances, Supplies and Wound
Care Devices.
The UND Aerospace Foundation
Single
Grand Forks
ND
USA
ISO 9001:2008
Developing and conducting training programs, research and development, custom software
development and consulting services related to the aerospace industry.
Thermedx LLC
Single
Solon
OH
USA
ISO 13485/CMDCAS
Thermo Scientific Portable Analytical
Single
Tewksbury
MA
USA
ISO 9001:2008
Teradyne Suzhou Suzhou
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Manufacturer of In-Circuit and Functional Automated Test Equipment for Commercial, Military,
and Aerospace Industries.
The design, manufacture and distribution of active warming systems for infusion and irrigation
and related accessories.
Design, Manufacture and Distribution of Portable Analytical Instruments
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Thorlabs Quantum Electronics
Single
Jessup
MD
USA
ISO 9001:2008
THS International, Inc
Single
Indianapolis
IN
USA
ISO 13485/CMDCAS
Tool and Plastic Company Ltd
Single
Co. Longford
Ireland
ISO 9001:2008
Manufacture and assembly of plastic components for the medical device and healthcare
sector.
Tool and Plastic Company Ltd
Single
Ireland
EN ISO 13485:2012
Manufacture and assembly of plastic components for the medical device and healthcare
sector.
Tornier Orthopedics Ireland Ltd
Single
Co. Cork
Ireland
EN ISO 13485:2012
The manufacture and packaging of sterile orthopedic implants and related instrumentation
Transitions Optical, Inc.
Single
Pinellas Park
FL
USA
ISO 14001:2004
The design and development of photochromic technology and the photochromic treatment of
lenses for the global opthalmic market.
Translational Research Institute (TRI)
Single
Gilbert
AZ
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of non-active catheters for cardiovascular infusion.
Transpire, Inc.
Single
Gig Harbor
WA
USA
ISO 9001:2008
Develop and deliver software solutions, provides software related training, and provides
engineering services (utilizing the software) to accurately predict the macroscopic behaviour
of radiation
Trend Technologies Mullingar Ltd.
Single
Co. Westmeath
Ireland
ISO 14001:2004
The manufacture and assembly of precisiom plastic injection mouldings.
Trend Technologies Mullingar Ltd.
Single
Co. Westmeath
Ireland
ISO 9001:2008
The manufacture and assembly of precisiom plastic injection mouldings.
TriVascular, Inc.
Single
Santa Rosa
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of implantable devices for the treatment of
descending thoracic aneurysm, abdominal aortic aneurysm and related delivery devices and
accessories.
TROY Group, Inc.
Single
Wheeling
WV
USA
ISO 9001:2008
The design, development, manufacture, service and technical support of MICR and specialty
printing supplies, printer solutions and the qualification and manufacturing of secure digital
printing systems
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Longford
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Designs, develops, manufactures, and provides repair services for advanced semiconductor
and Lithium Niobate optical components, subsystems, and devices for the photonics market.
The Design, Manufacture and Distribution of Disposable Urologic Catheters and Stone Control
Devices.
4/10/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Trulife
Secondary
Dublin 24
Ireland
EN ISO 13485:2012
The design, manufacture and customer support of silicone and foam breast prostheses,
antidecubitis products and operating room theatre supports.
Trulife
Primary
Dublin 24
Ireland
EN ISO 13485:2012
The design, manufacture and customer support of silicone and foam breast prostheses,
antidecubitis products and operating room theatre supports.
The contract manufacture and supply of components and assemblies used in the medical
industry
Turner Medical Inc.
Single
Athens
AL
USA
ISO 13485:2003
Typenex Medical LLC
Single
Chicago
IL
USA
EN ISO 13485:2012
Primary
Hsinchu City
Taiwan, R.O.C.
TL 9000 R5.0/5.0
TL 9000-H Scope: Design and Manufacture of Wireless Access Point (AP)/
Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server Product for the following
service category: 6.2.4 Digital Data Service Units.QMS Scope: Design and Manufacture of
Wireless Access Point (AP)/Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server.
Taiwan
TL 9000 R5.0/5.0
TL 9000-H Scope: Design and Manufacture of Wireless Access Point (AP)/
Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server Product for the following
service category: 6.2.4 Digital Data Service Units.QMS Scope: Design and Manufacture of
Wireless Access Point (AP)/Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server
U-Media Communications, Inc.
U-Media Communications, Inc.
The design, manufacture and distribution of blood sampling and dispensing accessories for
use during In-Vitro diagnostic testing.
Secondary
Hukou
UNICOR Federal Prison Industries
Single
Victorville
CA
USA
ISO 9001:2008
The rebuilding and servicing of vehicles and related components.
UNICOR Federal Prison Industries, Inc.
Single
Petersburg
VA
USA
ISO 9001:2008
The Manufacture and Production of Government and Bound Paper Products.
UNICOR Federal Prison Industries, Inc.
Single
Bastrop
TX
USA
ISO 9001:2008
Manufacture and installation of vehicular up-fit installation products.
UNICOR Federal Prison Industries, Inc.
Single
Texarkana
TX
USA
ISO 9001:2008
The production of air conditioning filters.
UNICOR Federal Prison Industries, Inc.
Single
Sandstone
MN
USA
ISO 9001:2008
Manufacturer of Printed Products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
UNICOR Federal Prison Industries, Inc.
Single
Miami
FL
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Lexington
KY
USA
ISO 9001:2008
The manufacture of cables and printed circuit boards.
UNICOR Federal Prison Industries, Inc.
Single
Jesup
GA
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Florence
CO
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
White Deer
PA
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Ashland
KY
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Terminal Island
CA
USA
ISO 9001:2008
Manufacture, assembler and shipper of metal and industrial products.
UNICOR Federal Prison Industries, Inc.
Single
Anthony
TX
USA
ISO 9001:2008
Service and delivery of vehicular up-fit installation products.
UNICOR Federal Prison Industries, Inc.
Single
Beaver
WV
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Milan
MI
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Coleman
FL
USA
ISO 9001:2008
Manufacture and assembly of office products.
UNICOR Federal Prison Industries, Inc.
Single
Lompoc
CA
USA
ISO 9001:2008
The Manufacture of Industrial Sign Products.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
UNICOR Federal Prison Industries, Inc.
Single
Forrest City
AR
USA
ISO 9001:2008
Manufacture and Assembly of Office Furniture.
UNICOR Federal Prison Industries, Inc.
Single
Minersville
PA
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Pennington Gap
VA
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Butner
NC
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Waseca
MN
USA
ISO 9001:2008
The Manufacture of Clothing and Textile Products
UNICOR Federal Prison Industries, Inc.
Single
Edgefield
SC
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Inez
KY
USA
ISO 9001:2008
Textile Manufacturing
UNICOR Federal Prison Industries, Inc.
Single
Yazoo City
MS
USA
ISO 9001:2008
Manufacture of Textile Clothing/Products.
UNICOR Federal Prison Industries, Inc.
Single
Butner
NC
USA
ISO 9001:2008
The manufacture of industrial products for governmental agencies
UNICOR Federal Prison Industries, Inc.
Single
Pekin
IL
USA
ISO 9001:2008
Design and fabrication of governmental industrial metal products.
UNICOR Federal Prison Industries, Inc.
Single
Memphis
TN
USA
ISO 9001:2008
Manufacture of Electrical Cables for Governmental Agencies.
UNICOR Federal Prison Industries, Inc.
Single
Loretto
PA
USA
ISO 9001:2008
The manufacturer of electronic cable assemblies and installation kits.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
UNICOR Federal Prison Industries, Inc.
Single
Fairton
NJ
USA
ISO 9001:2008
Manufacture of Cable Assemblies, Wiring Harnesses, Battery Boxes and Injection Molding
(Rubber and Plastic).
UNICOR Federal Prison Industries, Inc.
Single
Glenville
WV
USA
ISO 9001:2008
The rebuilding and servicing of vehicles and related components
UNICOR Federal Prison Industries, Inc.
Single
Butner
NC
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Marion
IL
USA
ISO 9001:2008
Manufacture of electronic cable assemblies and wiring harnesses
UNICOR Federal Prison Industries, Inc.
Single
Littleton
CO
USA
ISO 9001:2008
The Manufacture of Clothing/Textile products.
UNICOR Federal Prison Industries, Inc.
Single
Leavenworth
KS
USA
ISO 9001:2008
The Manufacture and Production of Printed and Bound Paper Products.
UNICOR Federal Prison Industries, Inc.
Single
EL RENO
OK
USA
ISO 9001:2008
Sheet metal fabrication
UNICOR Federal Prison Industries, Inc.
Single
Danbury
CT
USA
ISO 9001:2008
The manufacture and assembly of Electronic Components
UNICOR Federal Prison Industries, Inc.
Single
Pollock
LA
USA
ISO 9001:2008
The Manufacture of Clothing and Textiles.
Unilife Medical Solutions, Inc.
Single
York
PA
USA
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Sterile Safety Syringes,
Ready to Fill Syringe Components, and Active and Non-Active Drug Injection Systems.
Unimed Surgical Products, Inc.
Single
Largo
FL
USA
EN ISO 13485:2012
Manufacture and packaging of sterile and non-sterile electrosurgical instruments.
Unisys Corporation
Single
Irvine
CA
USA
ISO 14001:2004
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Supply Chain Operation that Provides Order Fulfillment, Mechanical Assembly and Test, Drop
ship and Logistics Activities for Unisys Enterprise-class Server Products and Services.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Unisys Corporation
Single
Irvine
CA
USA
ISO 9001:2008
Suppy Chain Operation that Provides Order Fulfillment, Mechanical Assembly and Test, Drop
Ship and Logistics Activities for Unisys Enterprise-class Server Products and Services.
United Drug
Single
Co Mayo
Ireland
ISO 9001:2008
The Wholesaling and distribution of pharmaceutical products, distribution of consumer
products and the supply of medical equipment and consumables
United Drug Plc
Single
Dublin 24
Ireland
ISO 9001:2008
The distribution of pharmaceuticals, consumer products, cosmetic, photographic and medical
equipment. The servicing of medical equipment.
US Endodontics
Single
Johnson City
USA
ISO 13485/CMDCAS
CMDCAS Scope: The Design, Manufacture and Distribution of Endodontic Obturators,
Verifiers and Dental Rotary Files.MD Scope: The Manufacture and Distribution of Endodontic
Obturators, Verifiers and Dental Rotary Files.
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision
Machined Components, Electromechanical Assemblies including Cable Harnesses.ISO 13485
Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined
Components, Electromechanical Assemblies including Cable Harnesses integrated into
Medical Devices.
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision
Machined Components, Electromechanical Assemblies including Cable Harnesses.ISO 13485
Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined
Components, Electromechanical Assemblies including Cable Harnesses integrated into
Medical Devices.
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision
Machined Components, Electromechanical Assemblies including Cable Harnesses.ISO 13485
Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined
Components, Electromechanical Assemblies including Cable Harnesses integrated into
Medical Devices.
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision
Machined Components, Electromechanical Assemblies including Cable Harnesses.ISO 13485
Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined
Components, Electromechanical Assemblies including Cable Harnesses integrated into
Medical Devices.
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision
Machined Components, Electromechanical Assemblies including Cable Harnesses.ISO 13485
Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined
Components, Electromechanical Assemblies including Cable Harnesses integrated into
Medical Devices.
COMPANY
Vander-Bend Manufacturing
Vander-Bend Manufacturing
Vander-Bend Manufacturing
Vander-Bend Manufacturing
Vander-Bend Manufacturing
Secondary
Secondary
Primary
Secondary
Sunnyvale
Sunnyvale
Sunnyvale
Santa Clara
TN
CA
CA
CA
CA
USA
USA
USA
USA
Secondary
Sunnyvale
CA
USA
EN ISO 13485:2012
VarData LLC
Single
Rochester
NY
USA
ISO 9001:2008
Reseller of technology for voice, data and storage networks for both enterprise and service
providers.
Varian Medical Systems, Inc.
Single
Atlanta
GA
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Medical Imaging Software
for Radiation Therapy and Oncology.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
COMPANY
Vasorum Ltd.
Profile
Type
CITY
Single
STATE
Country
Scheme
Scope
Dublin 24
Ireland
EN ISO 13485:2012
The design, manufacture and distribution of minimally invasive, non-active devices for closure
of vascular punctures
Velco Tool & Die, Inc
Primary
Lake Forest
CA
USA
ISO 13485:2003
Manufacture of plastic and metal components for the medical device industry.
Velco Tool & Die, Inc
Secondary
Lake Forest
CA
USA
ISO 13485:2003
Manufacture of plastic and metal components for the medical device industry.
Velocity Electronics
Single
Austin
TX
USA
AS 9120:2009
The inspection, storage, and distribution of electronic components and related products and
the performance of supply chain solutions.
Velocity Electronics, LP
Single
Austin
TX
USA
ISO 14001:2004
The inspection, storage, and distribution of electronic components and related products and
the performance of supply chain solutions.
Velocity Electronics, LP
Single
Austin
TX
USA
OHSAS 18001:2007
The inspection, storage, and distribution of electronic components and related products and
the performance of supply chain solutions.
Veryan Medical LTD
Single
Co. Galway
Ireland
EN ISO 13485:2012
The design, development and manufacture of non-active, implantable and non-implantable,
peripheral and coronary vascular devices and related delivery systems.
Volt Workforce Solutions
Primary
Orange
CA
USA
ISO 9001:2008
Provision of temporary staffing solutions
Volt Workforce Solutions
Secondary
Scottsdale
AZ
USA
ISO 9001:2008
Provision of temporary staffing solutions
Volt Workforce Solutions
Secondary
Raleigh
NC
USA
ISO 9001:2008
Provision of temporary staffing solutions
Wallac Oy
Secondary
Waltham
Wallac Oy
Single
Turku
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
USA
ISO 13485/CMDCAS
The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, invitro diagnostic instruments and software used in the diagnosis and monitoring of cancer,
fertility, endocrine disorders and in the management of maternalhealth screening, neonatal
screening, prenatal screening and as an aid in diagnosis.
Finland
ISO 9001:2008
The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, invitro diagnostic analysers used in the diagnosis and management of cancer, neonatal
screening, pre-natal screening, endocrine disorders,autoimmune diseases, diabetes,
anaemia, infectious diseases and disease status.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
Primary
Wallac Oy, PerkinElmer Oy
Wallac Oy, PerkinElmer Oy
COMPANY
Country
Scheme
Turku
Finland
ISO 13485/CMDCAS
The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, invitro diagnostic instruments and software used in the diagnosis and monitoring of cancer,
fertility, endocrine disorders and in the management of maternalhealth screening, neonatal
screening, prenatal screening and as an aid in diagnosis.
Single
Turku
Finland
OHSAS 18001:2007
Research, product development, production, domestic sales and service, and technical
support of instruments, reagents and software in the business areas of analytical and
diagnostic systems.
Single
Turku
Finland
ISO 14001:2004
Research, product development, production, dosmestics sales and service, and technical
support of instruments, reagents and software in the business areas of analytical and
diagnostic systems.
Waterford Intellectual Diasability
Secondary
Waterford
Ireland
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day
services
Waterford Intellectual Disability
Primary
Co Waterford
Ireland
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day
services
Waterford Intellectual Disability
Secondary
Co Waterford
Ireland
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day
services
Waterford Intellectual Disability
Secondary
Waterford
Ireland
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day
services
Waterford Intellectual Disability
Secondary
Waterford
Ireland
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day
services
West Point Products, LLC.
Single
Washington
PA
USA
ISO 9001:2008
Warehousing and Distribution of Laser, Inkjet, Impact Printer Cartridges and Other Printing
Consumables.
WestFab Manufacturing
Single
Santa Clara
CA
USA
ISO 9001:2008
Manufacture of precision sheet metal, machining and assemblies.
Whitman Products
Single
North Andover
MA
USA
ISO 9001:2008
Contract manufacturer of Electronic Assemblies, servicing the Instrumentation Commercial,
Military, Telecommunications, RF, Medical, Industrial and Automotive Industries.
Winchester Laboratories, LLLP
Single
Riviera Beach
FL
USA
ISO 13485/CMDCAS
Wallac Oy
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
Manufacture and distribution of sterile saline for topical use.
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
WONIK Quartz International Corporation
Single
Albuquerque
NM
USA
ISO 9001:2008
The manufacture of Quartz glassware for the semiconductor fabrication industry.
Xandex, Inc.
Single
Petaluma
CA
USA
ISO 9001:2008
The Design, Development and Manufacture of Test and Assembly Equipment for the
Semiconductor Industry and Products for the Renewable Energy Industry.
Xcaper Industries, LLC
Single
Irvine
CA
USA
ISO 9001:2008
The manufacture of moist direct contact filter and mask for smoke, gas protection, particulate
matter and vapors from smoke.
COMPANY
Scope
Xeridiem Medical Devices
Single
Tucson
AZ
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Packaged Sterile and Bulk
Non-Sterile Catheters, Tubing and Tubing Sets, Drainage Devices, and Stoma Devices for
Cardiovascular, Peripheral, Urological, and Enteral Feeding Applications,Surgical Instruments
and Cardiac Leads.
Xhale Assurance, Inc
Single
Glastonbury
CT
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Servicing and Distribution of Monitors and Sensors
for Pulse Oximetry and Respiratory Rate.
Xhale Smart, Inc
Single
Gainesville
FL
USA
EN ISO 13485:2003
Design, Development, and Manufacturing of Drug Adherence Monitoring Systems.
Ximedica, LLC
Single
Providence
RI
USA
EN ISO 13485:2012
The provision of product design, engineering and contract manufacturing services for medical
device customers. Assembly and packaging of electro-mechanical capital medical devices
and assembly, packaging of sterile/non-sterile medical disposables.
XLA Inc.
Single
Springfield
VA
USA
ISO 9001:2008
Corporate management services for employee time keeping, payroll, and invoicing relating to
the supply of program management, engineering and technical, and international missionsupport services across a variety of Government and commercialcontracts.
Yealy Optic Electronic Co., Ltd.
Single
Taichung City
Taiwan, R.O.C.
ISO 9001:2008
LED Visual Detection Service for LED Display and LED Lighting Device Industries.
Yealy Optic Electronic Co., Ltd.
Single
Taichung City
Taiwan, R.O.C.
YSI, Inc.
Primary
Yellow Springs
OH
USA
ISO 13485/CMDCAS
The design, manufacture and service of glucose and lactate monitoring instruments and
reagents used in medical applications.
YSI, Inc.
Secondary
Yellow Springs
OH
USA
ISO 13485/CMDCAS
The design, manufacture and service of glucose and lactate monitoring instruments and
reagents used in medical applications.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
ECCB Manufacture App LED Visual Detection Service for LED Display and LED Lighting Device Industries
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
4/10/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Laureldale
PA
USA
ISO 9001:2008
The design, manufacture and distribution of lead acid batteries and accessories.
Zehnacker Healthcare Ireland
Primary
Co Kildare
Ireland
ISO 9001:2008
The Provision of decontamination and sterilization services, and facility cleaning and catering
services.
Zehnacker Healthcare Ireland
Secondary
Dublin 11
Ireland
ISO 9001:2008
The Provision of decontamination and sterilization services, and facility cleaning and catering
services.
Zehnacker Healthcare Ireland
Secondary
Dublin 9
Ireland
ISO 9001:2008
The Provision of decontamination and sterilization services, and facility cleaning and catering
services.
Zehnacker Healthcare Ireland
Secondary
Co Waterford
Ireland
ISO 9001:2008
The Provision of decontamination and sterilization services, and facility cleaning and catering
services.
Zehnacker Ireland Healthcare
Secondary
Dublin 11
Ireland
EN ISO 13485:2012
MD Scope: The Provision of Decontamination and Sterilization Services for Reusable Medical
Devices.ISO9K Scope: The Provision of decontamination and sterilization services, and
facility cleaning and catering services.
Zehnacker Ireland Healthcare
Primary
Co. Kildare
Ireland
EN ISO 13485:2012
MD Scope: The Provision of Decontamination and Sterilization Services for Reusable Medical
Devices.ISO9K Scope: The Provision of decontamination and sterilization services, and
facility cleaning and catering services.
Zhone Technologies, Inc.
Single
Largo
FL
USA
ISO 9001:2008
Manufacture and service of electronic telecommunications equipment.
Ziehl-Abegg, Inc.
Single
Greensboro
NC
USA
ISO 9001:2008
The assembly and distribution of axial and centrifugal fans and external rotor motors.
COMPANY
Yuasa Battery, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
Scope
4/10/2015