Certificate EG04/61970
The management system of
Pharmaplast S.A.E
Amiria factory, Amiria free zone,
Alexandria, Egypt
has been assessed and certified as meeting the requirements of
ISO 9001 :2008
For the following activities
The scope of registration appears on page 2 of this certificate.
Further clarifications regarding the scope of this certificate and the applicability of
ISO 9001 :2008 requirements may be obtained by consulting the organisation
This certificate is valid from 23 May 2014 until 27 October 2015 and
remains valid subject to satisfactory surveillance audits.
Re certification audit due before 5 September 2015
Issue 5. Certified since 7 June 2004
This is a multi-site certification.
Additional site details are listed on the subsequent page.
Authorised by
~ UKAS
MANAGEMENT SYSTEMS 005
SGS United Kingdom Ltd Systems & Services Certification
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK
t +44 (0)151350-6666 f +44 (0)151 350-6600 www.sgs.com
SGS 9001-8 01 0311 M2
Page 1 of 2
This document is issued by the Company subject to its General Conditions of
Certification Services accessibte at www.sgs.com/tenms_and_conditions.hlm.
Attention is drawn to the limitations of liability. indemnification and jurisdictional
issues established lherein. The authenticity of lhis document may be verified at
hl1p:llwww.sgs.comieniOur-Company/Cer1ified-Client-Directones/Certified-CIient
Directories.aspx. Any unaulhorized alteration. forgery or falsification of lhe
content or appearance of this document is unlawlul and offenders may be
nrn5;Ar.IrtP.rt In fhp.
flll1p.~tp.Y1p.nl
nf thp.l~w
Certificate EG04/61970, continued
Pharmaplast S.A.E
ISO 9001 :2008
Issue 5
Detailed scope
The design and manufacture of adhesive tapes, sterile wound
dressings, sterile and non-sterile First Aid adhesive wound dressings
including Domiphen Bromide Medicated first aid wound dressings and
plaster of Paris bandage "Pharma-POP", Sterile "Kemagel" and
"Kemagel Comfort" hydrogel dressings. Sterile "All Wound" dressing.
Sterile "Pharmacoll", Pharmacoll Thin", Pharmacoll Basic" and
Pharmacoll Comfort" hydrocolloid wound dressings. Sterile
"ESPUMA" and "ESPUMA Comfort" polyurethane foam wound
dressings. Sterile "ESPUMA Silver" and "ESPUMA Comfort Silver"
polyurethane foam with silver wound dressing. Sterile "Pharmatull"
non-adherent paraffin impregnated gauze dressings. Silver Cure-Aid
adhesive plasters and wound dressings. "Pharmapad Silver",
"Pharmajelly Net" non-adherent lipocolloid impregnated wound
dressing. Sterile "Pharmacoll Ag", "Pharmacoll Ag Comfort",
"Pharmacoll Ag Thin", "Pharmacoll Ag Basic" and "Pharmacoll Ag
OTC" antimicrobial dressings. Hydrocolloid wound dressings
containing silver. Sterile "AbsoClear Gel" and AbsoClear Gel Comfort"
hydrogel dressings, Sterile Pharmapad carbon wound dressings,
Sterile and non-sterile AbsoClear OTC hydrogel dressings. Sterile
ESPUMA Comfort Plus & ESPUMA Comfort Silver Plus wound
dressings. Sterile "Salicol" saline wipes, sterile Pharma-Algi Alginate
wound dressings.
Manufacturing of Kemagel amorphous sterile healing gel
Provision of ethylene oxide sterilization for single use medical device
to the requirements of 15011135.
Manufacture of sterile incifilm theatre incise drape.
Further Clarifications regard ing the scope of this certificate and the applicability of
ISO 9001 :2008 requirements may be obtained by consulting the organisation
Additional faci lities
Second Site: Kafr AI-Zayat Factory, Kafr AI-Zayat" P.O. BOX 38, Egypt
This document is issued by the Compan y subiect to its General Conditions of
CertifiCation SeNices accessible at www.sgs.com/terms_and_conditions.htm.
Attentio n is drawn to the limitations of liability, indemnification and jurisdictional
issues established therein. The authenticity of this document may be verified at
hltp:llwl':w.sgs.C<lmlen/Our·Company/Certified·Client·DirectoriesiCertified·Client· Directories.asp'. Any unauthorized alleration, forgery or falsificatio n of the content or appearance of thi s documenl is unlawful and offenders may tie nrn!=:P.(';utprl to Ihl=! fHU P.~t p.xtp.nt of thl'!
I~w
Page 2 of 2
~ UKAS
MANAGEMENT SYSTEMS 005
EC Certificate Production Quality Assurance System: Certificate
EG11/83924
The management system of
Pharmaplast S.A.E
Amiria factory, Amiria free zone, Alexandria,
Egypt
has been assessed and certified as meeting the requirements of
Directive 93/42/EEC
on medical devices, Annex V
Restricted to the aspects of manufacture concerned with securing and
maintaining sterile conditions.
For the following products
The scope of registration appears on page 2 of this certificate.
This certificate is valid from 23 May 2014 until 27 October 2017 and
remains valid subject to satisfactory surveillance audits.
Re certification audit due before 27 October 2015
Issue 3. Certified since 21 March 2003
Certification is based on reports numbered EG/CAI P1208715
This is a multi-site certification.
Additional site details are listed on subsequent pages.
Authorised by
SGS United Kingdom Ltd, Notified Body 0120
2028 Worle Parkway. Weston-super-Mare, 8S22 6WA UK
t +44 (0) 1934 522917 f +44 (0)1934 522137 www.sgs.com
SGS CE 180811 M2
Page 1 of 2
EC Certificate Production Quality Assurance System: Certificate
EG11/83924, continued
Pharmaplast S.A.E
Directive 93/42/EEC
on medical devices, Annex V
Restricted to the aspects of manufacture concerned with securing and
maintaining sterile conditions.
Issue 3
Detailed scope
Sterile wound dressings: Sterile first aid dressings, Sterile Pharmapad
Carbon Wound Dressing
Sterile incifilm theatre incise drape.
Additional facilities
Second Site: Kafr AI-Zayat Factory, Kafr AI-Zayat" P.O. BOX 38, Egypt
Page 2of 2
Certificate EG03/58702
The management system of
Pharmaplast S.A.E
Amiria factory, Amiria free zone,
Alexandria, Egypt
SG$
has been assessed and certified as meeting the requirements of
ISO 13485:2003
EN ISO 13485:20t·2
For the following activities
The scope of registration appears on page 2 of this certificate.
This certificate is valid from 23 May 2014 until 27 October 2015 and
remains valid subject to satisfactory surveillance audits.
Re certification audit due before 5 September 2015
Issue 5. Certified since 21 March 2003
This is a multi-site certification.
Additional site details are listed on the subsequent page.
Authorised by
~ UKAS
MANAGEMENT
SYSTEMS
SGS United Kingdom Ltd Systems & Services Certification
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK
t +44 (0)151 350-6666 f +44 (0)151 350-6600 www.sgs.com
SGS 13485-2 0612 M2
Page 1of 2
This document is issued by the Company subject to its General Conditions of
Certification Services accessible at www.sgs.comltenms_and_conditions.htm.
Attention is drawn to the Iimnations of liabilny. indemnification and junsdictional
issues established therein. The authenticity of this documenl may be verified al
hltp:llwww.sgs.comienJOur·CompanylCertified·Client·DireetoriesICertified·Client·
Directories.aspx. Any unauthorized alteration, forgery or falsification of Ihe
eonlent or appearance of this document is unlawful and offenders may be
nrn~lItP.rl to Inp. fUIIp.d p.l1p.nt of thp. J;n'J
005
Certificate EG03/58702, continued
Pharmaplast S.A.E
ISO 13485:2003
EN ISO 13485:2012
SG$
Issue 5
Detailed scope
The design and manufacture of adhesive tapes, sterile wound dressings,
sterile and non-sterile First Aid adhesive wound dressings including
Domiphen Bromide Medicated first aid wound dressings and plaster of
Paris bandage "Pharma-POP", Sterile "Kemagel" and "Kemagel Comfort"
hydrogel dressings. Sterile "All Wound" dressing. Sterile "Pharmacoll",
Pharmacoll Thin", Pharmacoll Basic" and Pharmacoll Comfort"
hydrocolloid wound dressings. Sterile "ESPUMA" and "ESPUMA Comfort"
polyurethane foam wound dressings. Sterile "ESPUMA Silver" and
"ESPUMA Comfort Silver" polyurethane foam with silver wound dressing.
Sterile "Pharmatull" non-adherent paraffin impregnated gauze dressings.
Silver Cure-Aid adhesive plasters and wound dressings. "Pharmapad
Silver", "Pharmajelly Net" non-adherent lipocolloid impregnated wound
dressing. Sterile "Pharmacoll Ag", "Pharmacoll Ag Comfort", "Pharmacoll
Ag Thin", "Pharmacoll Ag Basic" and "Pharmacoll Ag OTC" antimicrobial
dressings. Hydrocolloid wound dressings containing silver. Sterile
"AbsoClear Gel" and AbsoClear Gel Comfort" hydrogel dressings, Sterile
Pharmapad carbon wound dressings, Sterile and non-sterile AbsoClear
OTC hydrogel dressings. Sterile ESPUMA Comfort Plus & ESPUMA
Comfort Silver Plus wound dressings. Sterile "Salicol" saline wipes, sterile
Pharma-Algi Alginate wound dressings.Manufacturing of Kemagel
amorphous sterile healing gel.
Provision of ethylene oxide sterilization for single use medical device to
the requirements of IS011135.
Manufacture of sterile incifilm theatre incise drape.
Additional facilities
Second Site: Kafr AI-Zayat Factory, Kafr AI-Zayat" P.O. BOX 38, Egypt
This document is issued by the Company subject to its General Conditions 01
Certification Services accessible at www.sgs .com/terms_and_conditions.htm.
Attention is drawn to the limitations of liab,lity, indemnification and juris dictional
issues established therein. The authenticity of this document may be verified at
http://www.s gs.corrJe niOur-CompanylCertified-Clie nt-DirectoriesfCertified-Client
Directories.aspx. Any unauthorized alteratio n. forgery or falsification of the content or appe arance of this document is unlawful and offenders may be nroC:p.(;ufp.ct to thp. hlllp~ f A'itp.nl nf thP. l::tw
Page 2 of 2
~ UKAS
MANAGEMENT SYSTEMS 005