115 results
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22ms
·
Sources: EU EUDAMED, US FDA
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
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.
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
1434-IVDD-260/2022
Certificate
IVDD Annex III Section 6·Sansure Biotech Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs
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
Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device