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Notification

Found : 24
 
  Body (History):

CeCert Sp. z o.o.
ul. ┼╗urawia 32/34 lok.49
Warszawa
Country : Poland

Phone : +48 721-721-527: +48 721-721-533,
Fax : -

Email : biuro@cecert.pl
Website : www.cecert.pl

Notified Body number : 2934

Version(s): 1 2

Last approval date : 05/11/2021
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last approval date : 03/01/2022
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
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0102 - Rhesus (C, c, D, E, e)
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0103 - Anti-Kell
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
*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 0301 - Anti-Duffy and anti-Kidd
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0302 - Irregular anti-erythrocytic antibodies
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0304 - Hereditary disease: phenylketonuria
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0306 - HLA tissue groups: DR, A, B
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0307 - Tumoral marker: PSA
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity Annex III  
   - *IVD 0402 - Haematology
EC declaration of conformity Annex III  
   - *IVD 0403 - Immunology
EC declaration of conformity Annex III  
   - *IVD 0404 - Molecular biology
EC declaration of conformity Annex III  
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity Annex III  
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity Annex III