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 9001. 2008 Certificate registration no. 306732 QM08 Certification I D 170505180 Date of certification 2010-10-23 Valid until 2013-10-22 Frank Graichen August-Schanz-Straße 21,60433 Frankfurt am Main, Tel. +49 (0) 69 95427-0, medical.devices@dqs.de
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 13485 : 2003 + AC. 2007 Certificate registration no. 306732 MP27 ***** Akkreditiert durch *... Zenlral8telle der L1nder Date of certification 2009-10-04 pp tur Geaundhel\88chutz ~ _ :- bel Arzneimitteln und Valid until 2012-09-29 "... *w ZLG-ZQ-9;.~9;;~86 Michael Drechsel Jan Böge August-Schanz-Straße 21,60433 Frankfurt am Main
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 13485 : 2003 + AC : 2007 Date of certification 2009-10-04 Valid until 2012-09-29 Registration Number: DE-306732 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 www.iqnet-certification.com
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 2012-09-29 Certificate Registration l'jo. 306732 MR2 Frankfurt am Main 2007-09-30 Ass. iur. M. Orechsel MANAGING OIRECTORS Oipl.-Ing. S. Hein10th 0-60433 Frankfurt am Main, August Schanz-Straße 21 EC code number of DQS as notified body: 0297
Annex to Certificate Registration No.: 306732 MR2 (edition 2007-09-30) Gunningerstr. 21 78606 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 (edition2007-09-30) is only valid in connection with the above-mentioned certificate.