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Notification

Found : 17
 
  Body (History):

VTT Expert Services Oy
PO Box 345
FI-33101 Tampere
Country : Finland

Phone : +358:20:722 111
Fax : +358:20:722 23494

Email : firstname.surname@vtt.fi
Website : www.vttexpertservices.fi

Notified Body number : 0537

Version(s): 1 2 3 4

Last update : 12/08/2014
 

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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 : 18/08/2016                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
*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)
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0202 - HTLV I and II
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0203 - Hepatitis B, C and D
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
*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
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0304 - Hereditary disease: phenylketonuria
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0307 - Tumoral marker: PSA
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
EC declaration of conformity (full quality assurance system) Annex IV  
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0403 - Immunology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0404 - Molecular biology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
 
Horizontal technical competence Limitations
*MDS 7205 - IVDs incorporating software / utilising software / controlled by software  
*MDS 7206 - IVDs in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), others (need to be specified)
*MDS 7210 - IVDs utilising material of human origin