CERTIF.ICATE. Gunningerstraße Seitingen-Oberflacht Germany
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1 CERTIF.ICATE DQS Medizinprodukte GmbH g[ [P[? (% Gunningerstraße 21 Design, Manufacturing, Marketing and sale of surgical instruments and implants for Osteosynthesis, Sterile Disposable Scalpels and Sterile Scalpel Blades ISO Certificate registration no QM08 Certification I D Date of certification Valid until Frank Graichen August-Schanz-Straße 21,60433 Frankfurt am Main, Tel. +49 (0) , medical.devices@dqs.de
2 CERTIFICATE DQS GmbH Deutsche Gesellschaft zur Zertifizierung von Managementsystemen g[3[p[? C% Gunningerstr. Zepf Medicallnstruments GmbH 21 Design, Manufacturing, Marketing and sale of surgical instruments and implants for Osteosynthesis, Sterile Disposable Scalpels and Sterile Scalpel Blades EN ISO : AC Certificate registration no MP27 ***** Akkreditiert durch *... Zenlral8telle der L1nder Date of certification pp tur Geaundhel\88chutz ~ _ :- bel Arzneimitteln und Valid until "... *w ZLG-ZQ-9;.~9;;~86 Michael Drechsel Jan Böge August-Schanz-Straße 21,60433 Frankfurt am Main
3 c=~====~-===~======~... THE INTERNATIONAL CERTIFICATION NETWORK CERTIFICATE IQNet and DQS GmbH Deutsche Gesellschaft zur Zertifizierung von Managementsystemen hereby certify that the company Zepf Medicallnstruments GmbH Gunningerstr. 21 Design, Manufacturing, Marketing and sale of surgical instruments and implants for Osteosynthesis, Sterile Disposable Scalpels and Sterile Scalpel Blades EN ISO : AC : 2007 Date of certification Valid until Registration Number: DE MP27 - (). Net ~{l~s~ ~ JBY ~ President of IQNet s of DQS mbh ~ IQNet Partners" AENOR Spain AFAQ AFNOR France AIB-Vinyotte International Belgium ANCE Mexico APCER Portugal CISQ Italy CQC China CQM China CQS Czech Republic Cro Cert Croatia DQS DS Denmark ELOT Greece FCA V Brazi/ FONDONORMA Venezuela HKQAA Hong Kong China ICONTEC Colombia IMNC Mexico InspectaCertification Finland IRAM Argentina JQA Japan KFQ Korea MSZT Hungary Nemko AS Norway NSAI Ireland PCBC Poland Quality Austria Austria RR Russia SAI Global Austra/ia SII Israel SIQ Siovenia SIR IM QAS International Malaysia SQS Switzerland SRAC Romania TEST St Petersburg Russia YUQS Serbia IQNet is represented in the USA by: AFAQ AFNOR, CISQ, DQS, NSAllnc. and SAI Global The list of IQNet partners is valid at the time of issue of this certificate. Updated information is available under
4 EC -CERTIFICATE DQS GmbH Deutsche Gesellschaft zur Zertifizierung von Managementsystemen g[][p[? C% Gunningerstr.21 has implemented and maintains a Quality Management System. An audit, documented in areport, performed by DQS has verified that this quality management system fulfills the requirements of Annex 11 of Directive 93/42/EEC with respect to the following medical devices: Surgical Instruments (lia /llb) and Implants for Osteosynthesis as per annex As set out in section 5, Annex 11, of the said directive, the manufacturer of these devices is subject to surveillance. This certificate is valid until Certificate Registration l'jo MR2 Frankfurt am Main Ass. iur. M. Orechsel MANAGING OIRECTORS Oipl.-Ing. S. Hein10th Frankfurt am Main, August Schanz-Straße 21 EC code number of DQS as notified body: 0297
5 Annex to Certificate Registration No.: MR2 (edition ) Gunningerstr Seitingen-Oberftacht Product groups Products Implants for Osteosynthesisfrom steel and Bone Nails (16-078) titanium Bone Plates (13-050) Bone Screws (13-101) Bone Wires (16-104) Osteotomy Staples (16-103) Surgical Instruments Sterile Disposable Scalpels (12-252) Sterile Scalpel Blades (12-252) HF I RF - Instruments Monopolar Forceps (16-860) Bipolar Forceps (16-860) This annex (edition ) is only valid in connection with the above-mentioned certificate.
CERTIFICATE IQNet and DQS GmbH Deutsche Gesellschaft zur Zertifizierung von Managementsystemen hereby certify that the company
CERTIFICATE IQNet and DQS GmbH Deutsche Gesellschaft zur Zertifizierung von Managementsystemen hereby certify that the company with the organizational units/sites as listed in the annex has implemented
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