0402 - 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

SP SWEDISH NATIONAL TESTING AND RESEARCH INSTITUTE
SP Box 857
SE- 501 15 Boras

T : 00 46 33165000
F : 00 46 33165610
URL : http://www.sp.se
Email :
cert@sp.se

Non-active devices specifically intended for recording of X-ray diagnostic images. (annex IX, 4.4. Rule 16)
Equipment for anaesthesia and intensive care
Bone anchored implants for dental and craniofacial reconstructions
Diagnostic X-ray equipment
Surgical instruments for single-use
Electromedical diagnostic equipment
Dental instruments 

Full quality assurance
Production quality assurance
Product quality assurance

 

 

 

Annex II
Annex V
Annex VI

 

 

 

 

Sterile devices in class I
Devices in class I with a measuring function

Production quality assurance
Product quality assurance

Annex V
Annex VI


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