0366 - NOTIFIED BODY (UNDER DIRECTIVE 93/42/EEC Medical devices)

Name and address of the notified bodie
Responsible for the following products
Responsable for the following procedures/modules
Annexes/articles of the directives

VDE e. V. - PRÜF - UND
ZERTIFIZIERUNGSINSTITUT

Benannt für : Merianstrasse,
2863069 Offenbach/Main

T : 00 49 69 83060
F : 00 49 69 8306.555

URL :
Email :

Active medical devices :

  • devices to ascertain vital functions
  • equipment for extracorporeal circuits, infusions and haemophoresis, excluding heart-lung machines
  • anaesthesia devices, incubators, respirators and oxygen therapy equipment
  • surgical equipment and ancillary surgical equipment
  • imaging equipment :
    • with ionizing radiation
    • with non-ionizing radiation
  • stimulation devices
  • radiotherapy equipment with non-ionizing radiation
  • ophtalmological devices
  • dental equipment
  • prostheses and rehabilitation devices
  • disinfection and sterilization equipment

Full quality assurance
Type-examination
EC verification
Production quality assurance
Product quality assurance

Annex II
Annex III
Annex IV
Annex V
Annex VI


site - http://www.hosmat.fr - dernière mise à jour : 10 janvier 2000