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Notification

Found : 11
  Body (History):

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 : -

Notified Body number : 0843

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

Last update : 13/08/2007
 

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices     (History)
Last update : 13/08/2007                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
All devices referred in Annex II, list A
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
Anti-duffy, anti-kidd, irregular anti-erythrocytic antibodies (list B)
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
Devices for diagnosing phenylketonuria, determining HLA tissue group: DR, A, B and evaluating trisomy 21
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Devices for the determination of PSA
Full quality assurance system Annex IV  
Devices for the determination of toxoplasmosis, rubella, cytomegalovirus and chlamydia
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
Own brand labelling of all Annex II and all self test devices which have existing NB certification via their original manufacturer
EC declaration of conformity
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex III
Annex IV
Annex V
Annex VI
Annex VII
 
Self diagnosis devices for coagulation
EC declaration of conformity
Full quality assurance system
Annex III
Annex IV
 
Self diagnosis devices for determining cholesterol
EC declaration of conformity
Full quality assurance system
Annex III
Annex IV
 
Self diagnosis devices for determining pregnancy and ovulation
EC declaration of conformity
Full quality assurance system
Annex III
Annex IV
 
Self diagnosis devices for diabetes management, urine analysis, endocrinology, general biochemistry and general immunology
EC declaration of conformity Annex III  
Self diagnosis devices for the determination of diabetes diagnosis and management, urine analysis, endocrinology, general biochemistry and chemsitry, and the determination of chlamydia infection and PSA
Full quality assurance system Annex IV  
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