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Institut Straumann AG ISO 13485

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t-CJl!=CEt¡JCJaoÊ¡c)t!CERTIFIGATENo. Q1 N 13 01 20326 037Holder of Gertificate:<strong>Institut</strong> <strong>Straumann</strong>Peter Merian-Weg 124002 BaselSwitzerland<strong>AG</strong>Product Service=Êtrl¿JCJaF\./Sest-CLl¡JCJaflrlnt-!rlil trt-!rlil trR'JrlI oatut-CJl!Gertification Mark:Scope of Gertificate:The Certification Body of TÜV SÜD PRODUCT SERVICE GMBH certifies that the company mentionedabove has established and is maintaining a quality system which meets the requirements ofthe listed standard(s). See also notes overleaf.Report No.:Valid from:Valid until:Date:2013-03-05Design and Development, Manufacturing and Distributionof lmplants, Regenerative Materials, ProstheticComponents, Planning and Design Software,lnvasive and Non-lnvasive lnstruments, AuxiliaryGomponents, Cassettes (Product and ProductRelated Services) for use in Oral and Extraorallmplantology (Maxillo-Facial Surgery)and Dental Prosthetic Restoration(see page 2 for additional locations)7130119132013-03-042016-02-28=CEu¡CJaFHans-Heiner Junkero@oØNV,---tcÊ,t¡JNPage 1 of 2TÜV SÜD Product Service GmbHZertifizierstelleRidlerstraße 65 . 80339 MünchenGermany*** *t *J=u*-: *rt*Akkreditiert durchZentralstelle der Länderfür Gesundheitsschutz,Gst**bei Arzneimittelnund Medizinprodukten* ^* ZLG-ZQ-999.98.12-46 TUV@


l-CJ-l!FCEt¡JCJaoc¡CJl!CERTIFICATENo. Ql N 13 01 20326 037Applied Standard(s):EN <strong>ISO</strong> <strong>13485</strong>:20121 AC:2012Medical Devices - Quality Management Systems-Requirement for Regulatory PurposesProduct Service=CE¡¡JCJaFvseSt-CLl¡JCJafitlut-trlil Bt-trlil trR'Jrlil trat¡Jl-Facility (ies):<strong>Straumann</strong> CADCAM GmbHLochhamer Schlag 6D-82166 Gräfelfing, GermanyDesign and development of Medical Software foruse in Oral and Extraoral lmplantology (Maxillo-Facial Surgery) and Dental Prosthetic Restoration<strong>Straumann</strong> CADCAM GmbHDüsseldorfer Platz 1D-09111 Chemnitz, GermanyDesign and development of Medical Software foruse in Oral and Extraoral lmplantology (Maxillo-Facial Surgery) and Dental Prosthetic Restoration<strong>Institut</strong> <strong>Straumann</strong> <strong>AG</strong>Gartenstrasse 143CH-4002 Basel, SwitzerlandWarehouse logistics and distributionCJḻ!FCEl¡JCJat-o@oØNVEFCEl¡JNPage 2 o1 2fÜv SÜo Product Service GmbHZertifizierstelleRidlerstraße 65 . 80339 MünchenGermany***i=+*-- *rt *

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