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Notification

Found : 19
  Body (History):

SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Trzaska cesta 2
1000 LJUBLJANA
Country : Slovenia

Phone : +386:1:4778 100
Fax : +386:1:4778 444

Email : info@siq.si
Website : -

Notified Body number : 1304

Version(s): 1 2 3 4 5 6 7 8

Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)
 

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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
Active medical devices
 
   - medical supply units
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - patient-monitoring equipment and equipment for recording vital functions
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - stimulation devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Blood pressure measurement devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Cannulas, probes and tubes
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Catheters and accessories
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Class I devices with a measuring function
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Electrical thermometers for clinical use
 
   - medical laser equipment
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Equipment and accessories for dialysis
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Equipment for the production, visualisation and processing of images using non-ionising radiation or ultrasound
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Equipment for treatment using non-ionising radiation or ultrasound
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Non-active medical devices
 
   - dental equipment and instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - dental implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - dental materials
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - disinfection and sterilization equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - orthopaedic implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
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