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CERTIFICATE
@
No: 50007/10UU20l1
G&G Contact Lens
40I,402 Beommul APT Type Factory 1287-l Beommul-dong
Suseong-Gu, Daegu, Korea
Certification body of management systems
hereby confirms that management system of above-mentioned organization has
been assessed and certified as meeting requirements of
ISO 13485: 2003
ror
Design, Production and distribution of Soft Contact Lens
Nova Dubnica. March 29^.2011 Ing. Karol Glamo5
The certificate is valid until March 28'h. 2014 Head of Certification body
EVPU a. s., Trendianska 19,
018 51 Nov6 Dubnica, Slovak Republic
gqN4l
www.evpu.sk Reg. No.010/Q-052
26. ffij
CERTIFICATE
No:5too7/e/2011
G&G Contact Lens
401,402 Beommul APT Type Factory 1287-1 Beommul-dong
Suseong-Gu, Daegu, Korea
Certification body of management systems
hereby confirms that management system of above-mentioned organization has
been assessed and certified as meeting requirements of
ISO 9001: 2008
for
Design, Production and distribution of Soft Contact Lens
Nova Dubnica, April 4th, 201 1 Ing. Karol Glamo5
The certificate is valid until April 3rd. 2014 Head of Certification body
g SNAS
Reg. No.010/Q-051
27. o
EVFU
NOTIFIED BODY No. 1293
EC CERTIFICATE
FULL QUALITY ASSURANCE SYSTEM
Directive 93l42lEEC on Medical devices, as amended by 2007147 lEC of the EP
and of the Council of 5'n September 2007, Annex ll (with the exemption of section 4),
transposed into "Slovak government decree No. 58212008 Coll. of Laws" as amended
No. 40042/1 01 11 t201 1 ICE
We hereby declare that an examination of the under mentioned full quality assurance system has been carried
out following the requirements of the national legislation to which the undersigned is subjected, transposing
annex ll (with the exemption of section 4) of the Directive 93142/EEc. as amended by 2007147IEC on medical
devices. We certiiy that the full quality assurance system conforms with the relevant provisions of the
aforementioned directive. ldentificatjon oflhe products covered by this certificate is given in the Appendix.
Manufacturer and Facility G&G CONTACT LENS Co.
40'l,40? Beommul APT Type Factory 1287 -'l Beommul-dong
Suseong-Gu, Daegu, Korea
Product(s) Soft Contact Lens
Product type(s) Soft (hydrophilic) contact lens I Single-Vision Hydrogel
Contact Lens
(more details are in Annex 1 of Final report)
Classification Medical Devices - Class lla
of medical device
Scope of guality system Quality of design, production, storage and distribution
of Soft Contact Lens
Final report number 4004?.t20111c
Date of issue April 7'n, 2011
Date of the end of validity April 6'", 2016
Karol G lam o5
,* ( t"r*,nn may only be used if all relevant and effective Directives ofEP and council are
C complied with.
12gS
The Notified Body has audited the quality system in accordance with the Direclive 93l42ltEc, as amended by
2O07l47lEC Annex ll (3) and found that the quality system meet the requirements of the Directive 93l42lEEC, as
amended by 2007/47lEC Annex ll.
The manufacturer must inform EVPU a.s of any plan far substantial changes in the design, construclion of lhe ptoducls ar Lhe
quattty system of pro.luctjon n ardet ta examine whether this Cefttficate remains valid Annual SuNeillance Audits wi be held to
ve fy the validity of this Cedificate.
This Ceftiflcate is valid Llntil the date specified. Any significant changes in the design ar canstruction of the producls, the qua ty
system or amendments lo the Dircctive 93/42/EEC as amended by 2007/47/EC may rcnder this Ceftificate nvalid aI an eafter
clate The procluct liabihty rcsts wlth tlrc manufacturet or his representative tn accodance with the Ditective B5/374/EEC.
O35 622 EVPIJ a.s, NB No. 1293. Trentianska 19, O18 51 Nove Dubnica, Stovak Republic, ryyy e!p! !4
Pascl/2
28. ,. ,l-:.:-:': .1,
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For Korean markets For abroad market6
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Maxim eolors,
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G&G BTII Fantasy,Noor Elegance, MX COLoR
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BR,W EYE FREE
TR
I fax BELLA
lfaxl
.,li
Amie CELLINI
Amie I
Jace
Lucy
SHINY
