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Bodies
Found : 19
Search criteria :
Legislation :
98/79/EC In vitro diagnostic medical devices
Procedure /
Article or annex :
ALL
EC declaration of conformity (full quality assurance system) / Annex IV
EC declaration of conformity (production quality assurance) / Annex VII
EC declaration of conformity / Annex III
EC type-examination / Annex V
EC verification / Annex VI
Full quality assurance system / Annex IV (22/11/2010)
Production quality assurance / Annex VII (22/11/2010)
Products :
ALL
*IVD 0100 - Reagents and reagent products, including related calibrators and control materials, for determining the f...
*IVD 0101 - ABO system
*IVD 0102 - Rhesus (C, c, D, E, e)
*IVD 0103 - Anti-Kell
*IVD 0200 - Reagents and reagent products, including related calibrators and control materials, for the detection, co...
*IVD 0201 - HIV infection (HIV 1 and 2)
*IVD 0202 - HTLV I and II
*IVD 0203 - Hepatitis B, C and D
*IVD 0204 - Variant Creutzfeldt-Jakob disease (vCJD)
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control mate...
*IVD 0301 - Anti-Duffy and anti-Kidd
*IVD 0302 - Irregular anti-erythrocytic antibodies
*IVD 0303 - Congenital infections: rubella, toxoplasmosis
*IVD 0304 - Hereditary disease: phenylketonuria
*IVD 0305 - Human infections: cytomegalovirus, chlamydia
*IVD 0306 - HLA tissue groups: DR, A, B
*IVD 0307 - Tumoral marker: PSA
*IVD 0308 - Risk of trisomy 21 (incl. software)
*IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
*IVD 0400 - Devices for self-testing
*IVD 0401 - Clinical chemistry
*IVD 0402 - Haematology
*IVD 0403 - Immunology
*IVD 0404 - Molecular biology
*IVD 0405 - Pregnancy and ovulation
*IVD 0406 - Specimen receptacles
*MDS 7205 - IVDs incorporating software / utilising software / controlled by software
*MDS 7206 - IVDs in sterile condition
*MDS 7207 - IVDs utilising micromechanics
*MDS 7208 - IVDs utilising nanomaterials
*MDS 7209 - IVDs utilising biological active coating and/or material
*MDS 7210 - IVDs utilising material of human origin
Horizontal technical competence :
ALL
*MDS 7205 - IVDs incorporating software / utilising software / controlled by software
*MDS 7206 - IVDs in sterile condition
*MDS 7207 - IVDs utilising micromechanics
*MDS 7208 - IVDs utilising nanomaterials
*MDS 7209 - IVDs utilising biological active coating and/or material
*MDS 7210 - IVDs utilising material of human origin
Withdrawn/Expired/Suspended Notifications/NBs are not displayed in this list, you can find them in the Body module under the hyperlink
"Withdrawn/Expired/Suspended Notifications/NBs"
Warning: As from 26 May 2022, the notified bodies designated under Directive 98/79/EC as listed here are no longer able to issue new certificates under that Directive, but only allowed to carry out surveillance activities for certificates validly issued under that Directive in the transitional period, as established in Article 110 of Regulation (EU) 2017/746.
Body type
Name
Country
NB 2265
3EC International a.s.
Slovakia
NB 0318
AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Spain
NB 2797
BSI Group The Netherlands B.V.
Netherlands
NB 2409
CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Hungary
NB 2934
CeCert Sp. z o.o.
Poland
NB 0344
DEKRA Certification B.V.
Netherlands
NB 1293
EVPU a.s.
Slovakia
NB 0537
Eurofins Electric & Electronics Finland Oy
Finland
NB 0459
GMED SAS
France
NB 1023
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Czech Republic
NB 0373
ISTITUTO SUPERIORE DI SANITA'
Italy
NB 0483
MDC MEDICAL DEVICE CERTIFICATION GMBH
Germany
NB 1011
NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)
Hungary
NB 0050
National Standards Authority of Ireland (NSAI)
Ireland
NB 1434
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Poland
NB 0543
Presafe Denmark A/S
Denmark
NB 0197
TÜV Rheinland LGA Products GmbH
Germany
NB 0123
TÜV SÜD Product Service GmbH
Germany
NB 2854
bqs. s.r.o.
Slovakia
European Commission - Growth