0413 - 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

SEMKO AB MedTech
P.O. Box 11 03
S - 16422 Kista

T : 00 46 87500271
F : 00 46 87500450

URL : http://www.semko.se
Email :
info@semko.se

 

Active therapeutic devices

Active devices intended for diagnosis

Actvie devices intended to administer and/or remove medicines, body liquids or other substances to or from body

  • Re-usable devices
  • Disposables
  • Wound dressings
  • Passive implants
  • Dental devices
  • Functional implants
  • Devices with a measuring function
  • Sterile devices

Full quality assurance
Production quality assurance
Product quality assurance

Annex II
Annex V
Annex VI

  • Electrical therapeutic devices
  • Electricial devices intended for diagnosis
  • Electrical devices intended to administer and/or remove medicines or products, body liquids or other substances to or from the body

Type-examination
EC verification

 

Annex III
Annex IV

 


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