0044 - 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

RWTÜV e.V. Zertifizierungsstelle für Gerätesicherheit, Aufzüge und Medizintechnik

Benannt für : Langemarckstrasse
2045138 Essen
GERMANY

T : 00 49 201 825 3216
F : 00 49 201 825 3209
URL :
Email :

Non-active medical devices :

  • orthopaedic implants,
  • soft tissue implants,
  • function implants,
  • disposable medical devices,
  • aneasthetic, orthopeadic and rehabilitation products,
  • non-energy medical instrumentation,
  • reusable non-active medical instruments,
  • bandages and dressings,
  • suture material and clamps,
  • dental equipment and instruments,
  • dental materials,
  • dental implants,

Active medical devicse :

  • devices to acsertain vital functions,
  • equipment for extracorporeal circuits, infusions and haemophoresis,
  • 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 devices :
    • with ionizing radiation,
    • with non-ionizing radiation,
  • ophtalmological devices,
  • dental equipment,
  • protheses and rehabilitation devices,
  • desinfection 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

0044 - NOTIFIED BODY (UNDER DIRECTIVE 90/385/EEC Active implantable 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

RWTÜV e.V. Zertifizierungsstelle für Gerätesicherheit, Aufzüge und Medizintechnik

Benannt für : Langemarckstrasse
2045138 Essen
GERMANY

T : 00 49 201 825 3216
F : 00 49 201 825 3209
URL :
Email :

 

All active implantable medical devices

Full quality assurance
Type-examination
EC verification
Production quality assurance

 

Annex II
Annex III
Annex IV
Annex V

 


site - http://www.hosmat.fr - dernière mise à jour / : 6 novembre 1999