Jel Soketli CE Sertifikası

ELEKTROTECHNICKY zKusEBNI USTAV
ELECTROTECHNICAL TESTING INSTITUTE - CZECH REPUBLIC
ELEKTROTECHNISCHE PRUFANSTALT - TSCHECHISCHE REI'UBLIK
INSTITUT ELECTROTECHNIQUE D'ESSAIS - REPUDLIQUE TCHEQUE
311EKTPOTEXHINECKHI1 HCnbITATEllbHhIH HHCTlITYT. YEWCKNl PECrJYGJll.1KA
Pod Lisem 129, 171 02 Praha 8 - Troja
•
CE BELGESI
tam kalite gtivence sistemi ivin
No.: MED 080046
Electroteehnieal Testing Institute,
imalatyl
Onaylanml~ Kurolu~
No. 10 14, Kalite Sistemini uygulanan
iSTEM MEDiKAL TIBi CiHAZ VE SAN. Tic. LTD. STi.
ivedik Org. Sanayi Bolgesi 661 Sok. Altm An Yap. Koop. No: 4 Ostim Ankara, Tiirkiye
tlbhi iiriinlerin tasanml, imalat, ve son kontrolU iCin
Neo-Cath jel soketli iiriner kateteri - slOlf IIa
tadilatlan dahil 93/421EEC Konsii( Direkititi Ek II b5!Um 3 gereksinimlerini
Bu karar, a~aglda numaraSl verilen rapor dikkate altnarak
0505.2007
kar~tIamaktadlf.
hazlrlanml~tlr.
Rapor No. 701340-07 Yaym Tarihi
Tadilatian dahil 93/42 EEC Direktiti § 17 gereksinimlerine gore yukanda tanlmlanan iiriinler CE I014
~ekilde etiketlenmelidir.
Betgelendirilmi~ kurulu~
i~areti ta~lyaeak
tadilatlan dahil 93/42 EEC Direktifi Ek II bOlUm 5 gereksinimlerine gore onaylanml~ kurlllu~
tarafmdan gozetim denetimine tabidir ve Belgenin geyerliligi periyodik denetimlerin olumlu gecmesine baghdlr.
imalatCl kalite sisteminde veya tlbbi iiriinlerin kapsammda eiddi degi~ikliklerle neticeleneeek her tiirlti faaliyel
hakkmda onaylanml~ kuru[u$u bilgilendirmek zorundadlr. Yaymlanml~ sertifikanln ko~ullanna aykm herhangi bir
durum meydana geldiginde, onaylanml~ kurulu~ Sertitikanm gecerliligini askJya alabilir veya Sertifikasl iptal edehilir.
SertifikaJ1111 gecerliliginin bittigi tarih: 30.9.2012
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11.8.2008
Prag
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04­
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~dk--
Pavel Kudrna
Belgelendirme ve Tetkik Mlldortl
KlCie
ELEKTROTECHNICKY zKusEBNI USTAV
ELECTROTECHNICAL TESTING INSTITUTE- CZECH REPUBLIC
ELEKTROTECHNISCHE PRUF ANSTALT - TSCHECHISCHE REPueUK
INSTITUT ELECTROTECHNIQUE D'ESSAlS - REPueUQUE TCHEQUE
3J1EKTPOTEXfll1'jECKI1H HCnbfTATEJlbHbl1i I1HCTIfTYT - 'fEWCJ<AJI PECIlY6J111KA
Pod Lisem 129, 171 02 Praha 8 - Troja
CE CERTIFICATE
of full quality assurance system
No,: MED 080046
The Electrotechnical Testing Institute, Notified Body No. 1014, has decided that Quality System applied by
manufacturcr
iSTEM MEDiKAL TIBi CiHAZ VE SAN. Tic. LTD. $Ti.
ivedik Org. Sanayi BOIgesi 661 Sok. Altm An Yap. Koop. No: 4 Ostim Ankara, Turkey
for design, manufacture and final inspection of medical devices
Neo-Cath urinary catheter with gel sachet - class lIa
complies with provisions of Annex 2 section 3 of Govemmental Order No. 33612004 CoIl. (Anncx II section 3 of the Council
Directive 93/42/EEC) incl. amendments,
This decision is based on the results presented in report No. 701340-07 of: 05,05,2007
In accordanee with Art. 5 of Governmental Order No, 336/2004 (Art, 17 of Directive 93/42IEEC), incl. amendments the
above specified medical device must be labelled CE 1014,
The certified manufacturer is subject to a surveillance audit by the notified body in accordance with section 5 of Annex
2 of Governmental Order No, 336/2004 CoiL (Annex II section 5 of Directive 93/42/EEC) inel. amendments, and validity
of the Certificate is subject to regular supervision, The manufacturer must inform the notified body about any intention
resulting in significant modification of quality system or scope of included medical produets. In the event that the
conditions under which the Certificate has been issued are violated, the notified body may suspend the Certifieate's
validity or cancel the Certif1catc,
The validity of Certificate is limited to: 30,9,2012
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U,8,2008
Prague
Pavel Kudrna
Certification and Inspection Manager
Stamp