24 results
·
9ms
·
Sources: EU EUDAMED, US FDA
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.
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market·3 countries
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market
Myo Rapid Quantitative Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Myoglobin (Myo) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Myoglobin (Myo) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Myo Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Myo Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Myo Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Myo Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Myo Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
cTnI/CK-MB/Myo Rapid Quantitative Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
cTnI/CK-MB/Myo (Cardiac panel) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
cTnI/CK-MB/Myo/D-Dimer/NT-proBNP Rapid Quantitative Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·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
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