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Cert{tcate of Compfunce
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We confirm that the technical documentation for the below mentioned product (medical devices of the Class
according to the Council Directive 93/42nEC
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Non-Sterile Reusable Surgical Instruments and Accessories
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(For detailed specifications refer to Annexure of this Certificate, Page 1)
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PAREVA MEDICAL SYSTEMS
A-1, PRANEEL C.H.S., LINK ROAD, OPP. ESKAY RESORTS, BORTVALI (WEST),
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complies with the applicable requirements of the Directive93/42{EEC.
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Referring to the intended use, the Certification Body has conducted with successful results the review of the
manufacturer's technical documentation of the certified product according to above mentioned Directive and
appropriate Harmonized European Standards.
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This Certificate is issued under the following conditions:
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The manufacturer's technical documentation, as required for class I devices, has been reviewed and found to comply
with the requirements in Annex VIl, Section 3.
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It applies only to the mentioned models of the medical devices.
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The manufacture is obligated to assure conformity of all the medical devices of the respective model to the type
assessed by the mean of this Certificate. The Certificate validity is conditioned by the positive results of the *1
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surveillance audits.
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Any significant changes in the design or process used to manufacture the product, or revision to the Directives or :d
standards referred above may require special audit by Eurotech Assessment and Certification Services Pvt. Ltd. The
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product liability rests with the manufacturer or his representative in accordance with council Directive.
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After fulfilling the relevant EU legislation requirements, the manufacturer shall affix to each medical device, of the
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above referenced models, CE-marking according to the following example:
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ET/Iv{DDl20l0l7zl
November 25,2410
November24,2015
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The Certificate remains the property of Eurotech Assessment and Certification Services
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URL: www.eurotechworld.net; E-mail: [email protected]
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PAREVA MEDICAL SYSTEMS
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List of the medical devices covered by the EC certificate:
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Forceps-
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Forceps Handles, Forceps
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Gyanecological Instruments
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Manipulators (Non-Sterile)
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Retractors (Non-Sterile)
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lip Applicators (Non-Sterile)
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Needle Holder (Non-Sterile)
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Probes
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Suction irrigation Cannula
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& Dissectors (Non-Sterile)
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Sheath & Bridges (Non-Sterile)
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Pre Bent Instruments (Non-Sterile)
Accessories (Non-Sterile)
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Clamps (Mono Polar
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ReducerV Bend Aoplicator/ Vaeinal Tubes
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Needle
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IrrigationV PCOD Needle/ Elevators/ Introducerv
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Cables for
Fiber Optic Endoscopes/ Connectors/ Adapters/ WasherV Working Element
(Active & Passive/ CapV Protection CoverV Holding Instruments/ Hollow
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Flexible, Semi Rigid, Articulating &
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Trocar Cannula (Non-Sterile)
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Dilators (Non-Sterile)
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Bipolar Forceps & Instnrments
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Issued for the company:
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No. ET/lVIDDlz0l0l7zl
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IssueDate :
Expiry Date :
Certificate
ETA4DDl20l0l72l
November25,20l0
November24,20l5
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