18 results
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17ms
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Sources: EU EUDAMED, US FDA
Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
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
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.
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
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH
TÜV Rheinland LGA Products GmbH
Notified body
🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs
3EC International a.s.
Notified body
🇸🇰 Slovakia·97 Manufacturers·166 Basic UDI-DIs
Eurofins Electric & Electronics Finland Oy
Notified body
🇫🇮 Finland·78 Manufacturers·851 Basic UDI-DIs
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body
🇵🇱 Poland·272 Manufacturers·5185 Basic UDI-DIs