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Notification

Found : 14
  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
98/79/EC In vitro diagnostic medical devices     (History)
Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
ABO system, rhesus (C, c, D, E, e) anti-Kell (list A)
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
All Annex II and all self-test devices which have existing notified body (NB) certification via their original manufacturer
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
All Annex II list B and all self-test devices which have existing notified body (NB) certification via their original manufacturer
EC verification Annex VI  
All self-test devices which have existing notified body (NB) certification via their original manufacturer
EC declaration of conformity Annex III  
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 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
 
HIV 1 and 2, HTLV I and II, and hepatitis B, C and D (list A)
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following hereditary disease: phenylketonuria
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
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
 
The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
Full quality assurance system Annex IV  
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