0537 - 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

VTT AUTOMATION
Medical Device Technology
P.O. Box 13052n Hermiankatu 8 D
SF- 33101 Tampere

T : 00 358 33163322
F : 00 358 33163365
URL : http: //www.vtt.fi
Email
: seppo.lavonen@vtt.fi

Active medical devices

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

 

Annex II
Annex III
Annex IV
Annex V
Annex VI

Non-active class I devices placed on the market in a sterile state

EC verification

Annex IV

Non-active class I devices with a measuring function

Production quality assurance

Annex V
Annex VI


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