EC-CERTIFICATE (Full quality assurance system) This is to certify that the company Champions-Implants GmbH Im Baumfeld 30 55237 Flonheim Germany has implemented and maintains a full quality assurance system which applies to the products at every stage from design to final controls. Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the management system fulfills the requirements of Annex II – excluding Section 4 of Council Directive 93/42/EEC concerning medical devices with respect to the following medical devices: Dental Implant Systems according to annex. The manufacturer is subject to surveillance according to Annex II, Section 5. The CE marking with the Notified Body Identification Number (0297) may be affixed on the devices listed in the certificate. An EC Design Examination Certificate according to Annex II, Section 4 is required for class III devices covered by this certificate. The certificate is in the case of class I(s) devices (I(s) = class I products placed on the market in sterile conditions) limited to the aspects of manufacture concerned with securing and maintaining sterile conditions. The certificate is in the case of class I(m) devices (I(m) = class I devices with a measuring function) limited to the aspects of manufacture concerned with the conformity of the products with the metrological requirements. Certificate registration no. Effective date Expiry date Dr. Thomas Feldmann Head of Certification Body August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] DQS Medizinprodukte GmbH is a Notified Body according to Council Directive 93/42/EEC concerning medical devices with the Identification Number 0297. Sigrid Uhlemann Managing Director
Open the catalog to page 1Certificate registration No.: 350734 MR2 Certificate unique ID: 170773907 Effective date: 2021-04-19 Im Baumfeld 30 55237 Flonheim Germany Device family Device Class Dental-Implant one-piece Dental-Implant- Square IIb Dental-Implant two-piece Dental-Implant two-piece IIb Equipment for Dental Prosthetic Accessories IIa Implant Systems This annex is only valid in connection with the above-mentioned certificate.
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