Certificate No. ID 60151739

Certificate Holder: INNOTERE GmbH

Meißner Str. 191
01445 Radebeul
Germany
Certificate Number: ID 60151739
Order Number: 3262834
Certified Product: Medical Device

Model Designation:
Bone substitute material Calcium phosphate bone cement

Fulfilled Standards: Richtlinie 93/42/EWG

The standard(s) listed here reflect the status at the time of the release of this certificate.
For more standards and/or upgrades please refer to the latest pages of the same certificate no.
Date of Issue: 2020-09-11
Certificate Type: EG-Auslegungsprüfbescheinigung MDD

EC - Design Dossier

The Design Examination according to EC directive 93/42/EEC, referred to as the EC Medical Device Directive (MDD), refers to the products mentioned in the certificate. It is certified that the design documentation of the product complies with Annex II, Article 4 of the directive. The manufacturer is subject to EC surveillance in accordance with Annex II, Article 5 of the directive. The manufacturer is entitled to use this certificate with the manufacturer's declaration of conformity.