Certificate No. 60113362

Certificate Number: 60113362
Certificate Holder: BERMED Sp. z o.o.
Zaklad Produkcyjno-Handlowy
ul. Ozynowa 51
53-009 Wroclaw
Poland
Scope:

Medical gas pipeline installations
Replaces Certificate, Registration no.: HD 60088317 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.