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Notification

Found : 9
  Body (History):

SP Sveriges Tekniska Forskningsinstitut AB
Box 857
501 15 BORAS
Country : Sweden

Phone : +46 (0) 10 516 50 00
Fax : +46 (0) 33 13 55 02

Email : info@sp.se
Website : www.sp.se

Notified Body number : 0402

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41

Last update : 26/04/2007
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update :
Products Procedures Articles/Annexes Limitations
All Class I sterile devices
Production quality assurance
Product quality assurance
Annex V
Annex VI
 
Bone anchored implants for dental and craniofacial reconstructions
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Class I devices with a measuring function
Production quality assurance
Product quality assurance
Annex V
Annex VI
 
Diagnostic X-ray equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Electromedical diagnostic equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Equipment for anaesthesia and intensive care
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Non active devices specifically intended for recording of X-ray diagnostic images. (Annex IX, 4.4. Rule 16)
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Surgical instruments for single use
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
dental devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
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