Certificate No. 60149099

Certificate Number: 60149099
Certificate Holder: GME German Medical Engineering GmbH

Grimmstr. 23
90491 Nürnberg
Germany
Scope:

- Diode Laser
- Excimer Lamp
- Multi-modality skin surface treatment system
(see attachment for additional sites included)
Replaces Certificate, Registration No.: HD 60123813 0001
Site included:
GME German Medical Engineering GmbH
Dreikönigstr. 6-8
91054 Erlangen
Germany

Fulfilled Standards: Richtlinie 93/42/EWG
Certificate Type: Vollst. QMS, Anhang II MDD

EC declaration of conformity (Full quality assurance system)
Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

This approval can be used by the company in line with the declaration of conformity.