29 results
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15ms
·
Sources: EU EUDAMED, US FDA
Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Sansure Biotech Inc.·1 device
Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Sansure Biotech Inc.·1 device
Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Sansure Biotech Inc.·1 device
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·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
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·1 device
No. V1 074552 0011 Rev. 02
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs
CeCert/115/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/116/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/117/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/118/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/119/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/120/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·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
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