0297 - 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

DQS - DEUTSCHE GESELLSCHAFT ZUR
ZERTIFIZIERUNG VON
MANAGEMENTSYSTEMEN mbH
QUALITÄTS UND UMWELTGUTACHTER
Benannt für : August Schanz strasse
2160433 Frankfurt/Main

GERMANY

T : 00 49 69 95427 0
F : 00 49 69 95427 111
 
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
  • protheses and rehabilitation devices
  • disinfection and sterilization equipment

Non-active medical products :

  • orthopaedic implants
  • function implants
  • disposable medical products
  • 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

Full quality assurance
Production quality assurance
Product quality assurance

Annex II
Annex V
Annex VI

0297 - 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

DQS - DEUTSCHE GESELLSCHAFT ZUR
ZERTIFIZIERUNG VON
MANAGEMENTSYSTEMEN mbH
QUALITÄTS UND UMWELTGUTACHTER
Benannt für : August Schanz strasse
2160433 Frankfurt/Main

GERMANY

T : 00 49 69 95427 0
F :00 49 69 95427 111
 
URL :
Email :

Active implantable medical devices (pacemakers, biostimulators, nerve stimulators, muscle stimulators, bladder stimulators, sphincter stimulators, diaphragm stimulator and ear stimulators)

Full quality assurance
Production quality assurance

Annex II
Annex V


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