European Commission - Enterprise and Industry

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Notification

Found : 10
 
  Body :

Gyógyszerészeti és Egészségügyi Minőség- és Szervezetfejlesztési Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute for Quality- and Organizational Development in Healthcare and Medicines Directorate of Device Testing and Engineering)
Diós árok 3
H-1125 Budapest
Country : Hungary

Phone : +36 1 356-1522
Fax : +36 1 375-7253

Email : cert@emki.hu
Website : www.emki.hu

Notified Body number : 1011

Version(s): 1 2 3

Last update : 25/10/2011
 

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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

Products Procedures Articles/Annexes Limitations
Devices for self-testing
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
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 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 blood groups: anti-Duffy and anti-Kidd
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
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 human infections: cytomegalovirus, chlamydia
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 tumoral marker: PSA
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis
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
EC verification
Production quality assurance
Annex IV
Annex VI
Annex VII
 
The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
Full quality assurance system
Production quality assurance
Annex IV
Annex VII