25 results
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8ms
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Sources: EU EUDAMED, US FDA
SARS-CoV-2 Antigen Rapid Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·On the market
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·On the market
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·On the market
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·On the market
CeCert/037/W/E.1
Certificate
IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
SARS-CoV-2 Antigen Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·1 device
1434-IVDD-254/2022
Certificate
IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
Chengdu Rich Science Industry Co., Ltd.
Manufacturer
🇨🇳 China·6 Basic UDI-DIs·7 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
Geratherm Medical GERMANY GmbH
Manufacturer
🇩🇪 Germany·20 Basic UDI-DIs·23 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
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.
Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer
🇨🇳 China·86 Basic UDI-DIs·107 Devices·5 Importers·TÜV Rheinland LGA Products GmbH, SGS Belgium NV, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer
🇨🇳 China·101 Basic UDI-DIs·130 Devices·14 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
TÜV SÜD Product Service GmbH
Notified body
🇩🇪 Germany·628 Manufacturers·12418 Basic UDI-DIs
BSI Group The Netherlands B.V.
Notified body
🇳🇱 Netherlands·376 Manufacturers·26587 Basic UDI-DIs
TÜV Rheinland LGA Products GmbH
Notified body
🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs
GMED SAS
Notified body
🇫🇷 France·180 Manufacturers·2196 Basic UDI-DIs
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body
🇵🇱 Poland·272 Manufacturers·5185 Basic UDI-DIs