Certyfikat numer 60107088

Numer Certyfikatu: 60107088
Certyfikowany właściciel: SORIMEX Spolka z ograniczona
odpowiedzialnoscia Sp. k.
ul. Równinna 25
87-100 Torun
Polska
Zakres:

(see attachment for products included)
Replaces Approval, Registration No.: HD 60036768 0001
Products included:
- Disposable SpO2 sensors
- Reusable SpO2 sensors
- Disposable temperature probes
- Reusable temperature probes
- Electrocardiographs

Spełnione Standardy: Richtlinie 93/42/EWG
Typ Certyfikatu: 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.