Certyfikat numer 60133560

Numer Certyfikatu: 60133560
Certyfikowany właściciel: BMV Bender Medical Vertrieb GmbH

Gewerbegebiet Bitzen 23
53804 Much
Niemcy
Zakres:

Medical devices for tracheostoma and wound care
(see attachment for products included)
Products included:
medical devices for tracheostoma care:
- tracheal-canula with/without cuff
- airway maintenance clips
- heat moisture exchangers/HME
- speech valves
- care oil
- disinfection solutions
medical devices for wound care:
- wound foams
For the following devices the scope covers only
the aspects of the manufacture concerned with
the securing and maintaining sterile conditions:
- drainage systems
- sterile tracheal compresses

Spełnione Standardy: Richtlinie 93/42/EWG
Organ Certyfikujący: TÜV Rheinland LGA Products GmbH
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.