EC Gertificate - Zhermack · EC Gertificate Product Service Full Quality Assurance System Directive...
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Product Service EC Gertificate Full Quality Assurance System Directive 931421ÉEC on Medical Devices (MDD), Annex ll excluding (4) (Devices in Class lla, llb or lll) No. G1 12 08 53618 016 Manufacturer: ZHERMACK S.p.A Via Bovazecchino, 100 45021 Badia Polesi ne (RO) ITALY Product Sterilizing Units, Steam Category(ies): The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex ll. This quality assurance system conforms to the requirements of this Directive and is subject to periodicalsurveillance. Formarketing of class llldevices an additionalAnnex ll (4)certificate is mandatory. See also notes overleaf. Report No.: tTA 225083 Valid from: Valid until: 2012-08-28 2017-08-27 Date, 2012-08-20 TÚV SÚD Product Service GmbH is Notified Bodv with identification no. 0123 Page 1 of2 TÚV SÚD Product Service GmbH . Zertifizierstelle RidlerstraBe 65 . 80339 Múnchen Germanv Hans-Heiner Junker TtlV@
Transcript of EC Gertificate - Zhermack · EC Gertificate Product Service Full Quality Assurance System Directive...
Product Service
EC GertificateFull Quality Assurance SystemDirective 931421ÉEC on Medical Devices (MDD), Annex ll excluding (4)(Devices in Class lla, llb or lll)
No. G1 12 08 53618 016
Manufacturer: ZHERMACK S.p.AVia Bovazecchino, 100
45021 Badia Polesi ne (RO)
ITALY
Product Sterilizing Units,SteamCategory(ies):
The Certification Body of TUV SUD Product Service GmbH declares that the aforementionedmanufacturer has implemented a quality assurance system for design, manufacture and finalinspection of the respective devices / device categories in accordance with MDD Annex ll.This quality assurance system conforms to the requirements of this Directive and is subject toperiodicalsurveillance. Formarketing of class llldevices an additionalAnnex ll (4)certificateis mandatory. See also notes overleaf.
Report No.: tTA 225083
Valid from:Valid until:
2012-08-282017-08-27
Date, 2012-08-20
TÚV SÚD Product Service GmbH is Notified Bodv with identification no. 0123
Page 1 of2
TÚV SÚD Product Service GmbH . Zertifizierstelle RidlerstraBe 65 . 80339 Múnchen Germanv
Hans-Heiner Junker
TtlV@
Product Service
EC CertificateFull Quality Assurance SystemDirective 93l42lEEC on Medical Devices (MDD), Annex ll excluding (4)(Devices in Class lla, llb or lll)
No. G1 12 08 53618 016
Facility(ies): ZHERMACK S.p.AVia Bovazecchino, 100, 45021 Badia Polesine (RO), ITALY
Page 2 of 2
:,
TUV SUD Product Service GmbH ' Zertifizierstelle RidlerstraBe 65 . 80339 Mùnchen Germanv TT'V@
