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Notification

Found : 7
  Body (History):

DANSK STANDARD - DANSK GODKENDELSE AF MEDICINSK UDSTYR
Kollegievej, 6
2920 CHARLOTTENLUND
Country : Denmark

Phone : +45/39.96.64.00
Fax : +45/39.96.64.01

Email : -
Website : -

Notified Body number : 0543

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

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
Devices for self-testing
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 controlling the following blood groups: ABO system, Rhesus (C, c, D, E, e), anti-Kell
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
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), and hepatitis B, and C
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 the detection, confirmation and quantification in human specimens of markers of HTLV 1 and 2
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
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