0125 - 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

LANDESGEWERBEANSTALT BAYERN ZERTIFIERUNGSSTELLE
Benannt für : Tillystrasse,
290431 Nürnberg

GERMANY

T : 00 49 911 655 5781
F : 00 49 911 655 5777
URL :
Email :

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

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

Annex II
Annex III
Annex IV
Annex V
Annex VI

 Dental implants

 

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

Annex VI
Annex II
Annex III
Annex IV
Annex V

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

0125 - 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

LANDESGEWERBEANSTALT BAYERN ZERTIFIERUNGSSTELLE
Benannt für : Tillystrasse,
290431 Nürnberg

GERMANY

T : 00 49 911 655 5781
F : 00 49 911 655 5777
 
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