Jel Soketli CE Sertifikası
Transkript
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 -- _.--- .. -- - -- . - 11.8.2008 Prag ~. 04 . ~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 -- ... - -- - . - - U,8,2008 Prague Pavel Kudrna Certification and Inspection Manager Stamp
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