0543 - 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

DGM Danish Medical Devices Certification
Kollegievej 6
DK - 2920 Charlottenlund

T : 00 45 39 96 64 00
F : 00 45 39966401
 
URL :
Email :
dgm@ds.dk

Active medical devices:

  • suction equipment
  • dental equipment
  • hearing aids and audiometers
  • electrocadiographs and electroencephalographs
  • sterilizers for medical devices
  • ultrasound equipment
  • patient monitoring equiipment
  • equipment for registration of life supporting functions
  • defibrilators
  • blood gas analyzers and anaesthetic monitors
  • electrosurgical equipment
  • surgical lasers
  • heart-lung mahines
  • equipment for planning radiation therapy
  • software for planning radiation therapy
  • equipment for stimulators
  • neonatal equipment

Non active medical devices

  • infusion equipment
  • bandages
  • drains, probes and suction equipment
  • surgical equipment
  • dental materials
  • dental implants
  • disinfectants
  • sutures and adhesives
  • contact lens fluids
  • condoms and contraceptive pessaries
  • intra-uterine contraceptives devices
  • surgical implants (excluding orthopedical implants and bone cement)
  • cardiovascular implants
  • contact lenses

EC Declaration of Conformity - Full quality assurance
EC Type-examination
EC verification
EC Declaration of conformity - Production quality Assurance
EC Declaration of conformity - Product quality Assurance
EC Design -Examination

 

Annex II
Annex III
Annex IV
Annex V
Annex VI
Annex II


site - http://www.hosmat.fr - dernière mise à jour : 10 janvier 2000