0047 - 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 SÜDWESTDEUTSCHILAND Rechtsnachfolger ist die TÜV Product Service GmbH München, Kenn-Nr. 0123 0483mdc - medical device certification GmbH
Benannt Für : Krautstasse
287700 Memmingen

GERMANY

T : 00 49 8331 9552 29
F : 00 49 8331 8552 55
URL :
Email :

Non -active medical devices :

  • orthopaedic implants,
  • disposable medical devices :
    • accessories for active medical devices,
    • syringes and infusion equipment for gravity infusion. 
  • aneasthetic, orthopeadic and rehabilitation products,
  • non-energy medical instrumentation : non invasive sphygmomanometers,
  • dental equipment and instruments,
  • dental materials,
  • dental implants,
  • disinfection means,
  • reusable non-active medical instruments,

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,

 

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

Annex II
Annex III
Annex IV
Annex V
Annex VI

Mercury thermometers

EC verification
Product quality assurance

Annex IV
Annex VI

Non-reusable scalpels

Full quality assurance

Annex II

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

0047 - 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 SÜDWESTDEUTSCHILAND Rechtsnachfolger ist die TÜV Product Service GmbH München Kenn-Nr. 0123 0483mdc - mdc - medical device certification GmbH
Benannt Für Krautstasse
287700 Memmingen

GERMANY

T : 00 49 8331 9552 29
F : 00 49 8331 8552 55
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