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Notification

Found : 8
  Body :

UL INTERNATIONAL (UK) LTD
Wonersh House Building C The Guildway Old Portsmouth Road
Guildford GU3 1LR
Country : United Kingdom

Phone : +44 1483 302130
Fax : +44 1483 302230

Email : Inform.NB@uk.ul.com
Website : http://www.ul-europe.com

Notified Body number : 0843

Version(s): 1 2 3 4 5 6 7 8 9

Last update : 28/04/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 27/11/2007                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
Active medical devices and their accessories
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
 
Disinfectants and surgical instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Gloves for medical use
EC verification Annex IV  
Non-active Class III cardiac catheters
Full quality assurance system Annex II  
Own Brand Labelling of all medical devices which have existing NB certification via their original manufacturer
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
 
Sterile single use medical devices excluding Class III devices, ophthalmic devices, (class IIa and above) and implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Urethral catheters
EC verification Annex IV  
Wound dressings (Class IIa and IIb)
EC type-examination
EC verification
Annex III
Annex IV
 
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