28 results
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16ms
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Sources: EU EUDAMED, US FDA
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer
🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
CeCert/086/W/E.1
Certificate
IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
SG Medical Inc.
Manufacturer
🇰🇷 South Korea·57 Basic UDI-DIs·57 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Sansure Biotech Inc.
Manufacturer
🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Beijing Strong Biotechnologies, Inc.
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH
BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer
🇨🇳 China·43 Basic UDI-DIs·43 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
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