0123 - 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

TÜV PRODUCT SERVICE gmbH Zertifizierstelle Benannt für : Ridlerstrasse 65,
D-80339 München

GERMANY

T : 00 49 89 5008 4280
F : 00 49 89 5008 4230

For FRANCE :

TÜV PRODUCT SERVICE
16 rue Martel
75010 PARIS

T : 01 53 34 94 70
F : 01 53 34 94 14
URL :http://www.tuvps.com
Email :
ddurand-viel@tuvps.com

Non-active medical devices:

  • orthopaedic implants
  • soft tissue implants
  • function implants
  • disposable medical devices
  • anaesthetic, orthopaedic 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 devices :

  • devices to ascertain 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
  • 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

0123 - 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

TÜV PRODUCT SERVICE gmbH Zertifizierstelle Benannt für : Ridlerstrasse 65,
D-80339 München

GERMANY

T : 00 49 89 5008 4280
F : 00 49 89 5008 4230

For FRANCE :

TÜV PRODUCT SERVICE
16 rue Martel
75010 PARIS

T : 01 53 34 94 70
F : 01 53 34 94 14
URL: http://www.tuvps.com
Email :
ddurand-viel@tuvps.com

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 : 30 mars 2000