Certificate No. 60108528

Certificate Number: 60108528
Certificate Holder: Fischer ANalysen
Instrumente GmbH
Brahestr. 25-27
04347 Leipzig
Germany
Scope:

Aspects of manufacture concerned with the conformity of
medical devices for respiratory gas analysis
with the metrological requirements
Replaces Approval, Registration No. HD 60038009 0001

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.