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  Body (History):

AGENCIA ESPAƑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS MINISTERIO DE SANIDAD Y CONSUMO
Paseo del Prado, 18-20
28014 MADRID
Country : Spain

Phone : +34:91:596 43 45
Fax : +34:91:596 44 00

Email : -
Website : -

Notified Body number : 0318

Version(s): 1 2

Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)
 

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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 :
Products Procedures Articles/Annexes Limitations
All devices for self-testing
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
 
Reagents and reagent products, including related calibrators and control materials, for controlling the following blood groups: ABO system, Rhesus (C, c, D, E, e), anti-Kell
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
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
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
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
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
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
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
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
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
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 type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
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