18 results
·
8ms
·
Sources: EU EUDAMED, US FDA
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·SG Medical Inc.·On the market
AMMONIA
Device
EU IVDD
·
Eu Ivd General
·Beijing Strong Biotechnologies, Inc.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC·On the market
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·1 device
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·1 device
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·1 device
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·1 device
InstaView COVID-19 Antigen Home Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·SG Medical Inc.·1 device
1434-IVDD-197/2022
Certificate
IVDD Annex III Section 6·SG Medical Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-260/2022
Certificate
IVDD Annex III Section 6·Sansure Biotech Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs
Ammonia Assay Kit (AMM)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beijing Strong Biotechnologies, Inc.·1 device
CIBG-20222721
Certificate
IVDD Annex III Section 6·Beijing Strong Biotechnologies, Inc.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
COVID-19 Antigen Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC·1 device
1434-IVDD-238/2022
Certificate
IVDD Annex III Section 6·BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI