Biopsy Needle CE Sertifikası

ELEKTROTECHNICKY ZKIJ SEBNI USTAV
ELECTROTECHNICAL TESTING TNSTITUTE - CZECH REPLTBLIC
ELEKTROTECHNISCHE PRUFANSTALT - TSCHECHISCHE REPL]BLIK
NSTITUT FLICTROTECH\IQLJE D'ESSAIs - REPLJBLIOLTE I CHbQUE
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CE CE,RTIFICATtr
of fulI quality assurance system
No.: MED 090006
The Electrotechnical Testing Institute, Notified Body No. 1014, has decided that Quality System applied by
manufacturer
isrnnr MEDiKAL TrBBi ciHAZ vE sAN. Tic. LTD. $Ti.
ivedik Org. Sanayi Bdlgesi 661 Sok. Altrn Arr Yapr Koop. No: 4 Ostim ANKARA, Turkey
for design, manufacture and final inspection ofmedical devices
Sterile biopsy needles and sets - class IIa, see enclosure
complies with provisions of Annex 2 section 3 of Govemmental Order No. 33612004 Coll. (Annex
Directive 93 I 42/EEC) incl. amendments.
II section 3 of the Cttuncil
This decision is based on the results presented in repoft No. 804537-03 of: 29.1 1.2008
In accordance with Art. 5 of Governmental OrderNo.336/2004 (fut. 17 of Directive 93l42lEEC), incl. amendmentsthe
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above specified medical device must be labelled CE 1014.
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The validity of Cerlificate is limited to:31.12.2013
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The certifled manufacturer is subject to a surveillance audit by the notified body in accordance with section 5 ofAnnex
2 of Govemmental Order No. 33612004 Coll. (Annex II section 5 of Directive 93l42lEEC) incl. amendments, and validity
ofthe 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 products. In the event that the
conditions under which the Certificate has been issued are violated, the notified body may suspend the Certificate's
validity or cancel the Certificate.
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Pavel Kudrna
Certif rcation and Inspection Manager
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804537-03
Enclosure to certificate No. MED 090006
BIOPSY NEEDLES AND SETS
Class IIa, sterile
Bone Marrow Biopsy Needle
Bone Marrow Biopsy Needle I Captura System
Bone Marrow Aspiration Needle
Chiba Biopsy Needle
Franseen Biopsy Needle
Westcott Biopsy Needle
Spinal Needle
Trocar Needle
Percutan Access Needle
Opticut Semi-Automatic Biopsy Needle
Vacumat Biopsy Needle
Automatic Biopsy Gun Needle
Opticore Automatic Biopsy Needle
Neogun Automatic Biopsy
Neocut Automatic Biopsy Gun Needle
B re ast L o cahzatron Needle
Bone Biopsy Needle
Needle Guide
Liver Biopsy Set
Galactography Set
Transbronchial Biopsy Needle
Shealed Needle
Coaxial Needle
Amniosynthesis Needle
Tumor Marking Needle
Coaxial Set - Chiba
Coaxial Set - Franseen
Coaxial Set - Westcott
Coaxial Set - Semi-Automatic
Coaxial Set - Automatic Gun Needle
Vertebroplasty Set
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ELEKTROTECHNI CKV ZKIJSgex I
US TAV
ELECTROTECHNICAl- TEST1NG INSTITUTE - CZECH REPL]BLIC
ELEKTROTECHNISCFIE PRUFANSTAIT - TSCHECHISCHE REPT]BLIK
TNSTITUT ELECTROTECH\IIQTJE D'ESSAtS - REPI BLIQL]E TCHL.QLft
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Praha 8 - Troja
CE BE,LGESI
tam kalite gi.ivence sistemi igin
No.: MED 090006
Electrotechnical Testing Institute, Onaylanmrg Kuruluq No. 1014, Kalite Sistemini uygulanan
MEDiKAL TrBBi ciHAZ vE sAN. ric. lro. gri.
ivedik Org. Sanayi Btilgesi 661 Sok. Altrn Arr Yapr Koop. No: 4 Ostim ANKARA, Tiirkiye
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ttbbi iiriinlerin tasanml, imalat, ve son kontrolti ipin
Steril biyopsi ifneleri ve setleri - srnrfIIa, ek'e bakrnlz
tadilatlan
d$il93l42lEEC Konsiil Direkitifi Ek II bctliim 3 gereksinimlerini karprlamakladr.
Bu karar,
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1
agaprda numarasl verilen rapor dikkate ahnarak hazrrlanmrgtlr. Rapor
No. 804537-03 Yayrn
Tarihi:
.2008
Tadilatlarr dahil 93142 EECDirektifi$ 17gereksinimlerinegoreyukandatanrmlananiirijnlerCE
1014igareti tagryacak
gekilde etiketlenmelidir.
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II bdliim 5 gereksinimlerine gdre onaylanmrg kuruluq
taraftndan gdzetim denetimine tabidir ve Belgenin gegerliligi periyodik denetimlerin olumlu gegmesine bafhclrr.
Imalat9l kalite sisteminde veya trbbi iiriinlerin kapsamrnda ciddi deligikliklerle neticelenecek her trirlti faaliyet
hakktnda onaylanmrg kurulugu bilgilendirmek zorundadrr. Yayrnlanmrp sertifikantn kogullarrna aykrl herhangi bir
durum meydana geldi[inde, onaylanmrg kurulug Sertifikanrn gegerlilifiini askrya alabilir veya Sertifikasr iptal edebilir.
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Sertifikanrn gegerliliginin bittifi tarih: 31.12.2013
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Belgelendirme ve Tetkik Mtidtirii
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804537-03
Bakmtz CE sertifikasi No.: MED 090006
BiYOPSI iGxEr-,ERi VE SETLERi
Srnrf IIa, steril
Kemik ilifii Biyopsi ifnesi
Kemik ilifi Biyopsi i[nesi / Captura Sistem
Kemik ilifii Aspirasyon i[nesi
Chiba Biyopsi ignesi
Fransen Biyopsi ignesi
Westcott Biyopsi i[nesi
Spinal i[ne
Trokar ilne
Perkiitan Giriqim ifnesi
Opticut Yan-Otomatik B iyopsi ignesi
Vacumat Biyopsi ifnesi
Otomatik Biyopsi Tabanca ignesi
Opticore Otomatik Biyopsi ignesi
Neogun Otomatik Biyopsi
Neocut Otomatik Biyopsi Tabanca i[nesi
Meme iqaretleme ignesi
Kemik Biyopsi ilnesi
I[ne Krlavuzu
Karacifer Biyopsi Seti
Galaktografi Seti
Transbronqiyal Biyopsi ifnesi
Shealed
ifne
Koaksiyel ifne
Amniyosentez ignesi
Tiimor igaretleme ilnesi
Koaksiyel Set - Chiba
Koaksiyel Set - Fransen
Koaksiyel Set - Westcott
Koaksiyel Set - Yarr-Otomatik
Koaksiyel Set - Otomatik Tabanca ilnesi
Vertebroplasti Seti
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