1,892 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdd
×
VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
NanoRepro SARS-CoV-2 Antigen Rapid Test (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
VIROLOGY - NA REAGENTS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·On the market
ALDOSTERONE
Device
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·On the market·32 countries
Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)
Device
EU IVDD
·
Eu Ivd General
·BioDetect(Xiamen)Biotechnology Co., Ltd.·On the market
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
VITAMIN B12
Device
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·On the market·32 countries
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
23andMe Personal Genome Service
Device
EU IVDD
·
Eu Ivd General
·23andMe, Inc.·On the market·5 countries
23andMe Personal Genome Service
Device
EU IVDD
·
Eu Ivd General
·23andMe, Inc.·No longer on the market·5 countries
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·On the market