14 results
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17ms
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Sources: EU EUDAMED, US FDA
Sanway Gene Tech. Inc.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Nucleix
Manufacturer
🇮🇱 Israel
HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·On the market·3 countries
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
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·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
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-199/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
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