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Notification

Found : 9
  Body (History):

SGS UNITED KINGDOM LIMITED
Worle Park, Weston-Super-Mare,
Somerset, BS22 6WA
Country : United Kingdom

Phone : +44 (0)1934 522917
Fax : +44 (0)1934 522137

Email : sgsprodcert@sgs.com
Website : www.uk.sgs.com

Notified Body number : 0120

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Last update : 18/11/2008
 

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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 [class I (measuring) and IIA only] which require compliance with EN 60601-1 and measurements of voltage, current, temperature, pressure, weight and time
EC verification Annex IV  
All medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Equipment and accessories for dialysis
 
   - Electrocardiographs
EC type-examination Annex III  
Infusion / syringe pumps
EC type-examination Annex III  
Male condoms
 
   - defibrillators
EC type-examination Annex III  
   - fever thermometers (active)
EC verification Annex IV  
   - fever thermometers (non-active)
EC verification Annex IV  
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