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EC Certificate - USA...EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical...
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Transcript of EC Certificate - USA...EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical...
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EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, llb or 111)
No. G1 13 04 81854 006
Man ufactu rer:
~[):~y '--" .( IMPLANTS
Product Category(ies):
DENTSPL Y lmplants Manufacturing GmbH Steinzeugstraße 50 68229 Mannheim GERMANY
Dental lmplants Maxillo Faciallmplants Abutments and Prosthetic Devices Instruments for Surgery and Prosthetics
Product Service
Bone Reconstruction Material and Fixation Devices
The Certification Body of TÜV SÜD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices I device categories in accordance with MDD Annex II. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class III devices an additional Annex II (4) certificate is mandatory. See also notes overleaf.
Report No.:
Valid from: Valid until:
Date, 2013-06-21
713021863
2013-07-01 2018-06-30
Hans-Heiner Junker
TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123
Page 1 of 2
TÜV SÜD Product Service GmbH · Zertifiziersteile · Ridlerstraße 65 . 80339 München . Germany
EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, llb or 111)
No. G1 13 04 81854 006
Facility(ies):
Page 2 of 2
DENTSPL Y lmplants Manufacturing GmbH Steinzeugstraße 50, 68229 Mannheim, GERMANY
DENTSPL Y IH AB (DENTSPL Y lmplants division) Aminogatan 1, PO Box 14,43121 Mölndal, SWEDEN
DeguDent GmbH (DENTSPL Y lmplants division) Rodenbacher Chaussee 4, 63457 Hanau, GERMANY
DENTSPL Y IH GmbH An der kleinen Seite 8, 65604 Elz, GERMANY
TÜV SÜD Product Service GmbH · Zertifiziersteile · Ridlerstraße 65 · 80339 München . Germany
Product Service
