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Found : 19
  Body :

Presafe Denmark A/S
Tuborg Parkvej 8
DK-2900 Hellerup
Country : Denmark

Phone : +45/39.45.49.99
Fax : -

Email : DGMservice@presafe.com
Website : www.presafe.com/dgm-denmark

Notified Body number : 0543

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

Last update : 18/09/2013
 

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last update : 17/11/2011                 Version(s): 1 2 3 4 5 6

Products Procedures Articles/Annexes Limitations
*IVD 0100 - Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups
 
   - *IVD 0101 - ABO system
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0102 - Rhesus (C, c, D, E, e)
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0103 - Anti-Kell
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
*IVD 0200 - Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of
 
   - *IVD 0201 - HIV infection (HIV 1 and 2)
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0202 - HTLV I and II
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0203 - Hepatitis B, C and D
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
 
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0307 - Tumoral marker: PSA
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
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
 
   - *IVD 0402 - Haematology
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
 
   - *IVD 0403 - Immunology
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
 
   - *IVD 0404 - Molecular biology
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
 
   - *IVD 0405 - Pregnancy and ovulation
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
 
   - *IVD 0406 - Specimen receptacles
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
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
*MDS 7210 - IVDs utilising material of human origin  
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