225 results
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8ms
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Sources: EU EUDAMED, US FDA
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
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.
Changsha Sinocare Inc.
Manufacturer
🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Apex Biotechnology Corp.
Manufacturer
🇹🇼 Taiwan·40 Basic UDI-DIs·40 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
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.
GC MEDIS Corp.
Manufacturer
🇰🇷 South Korea·31 Basic UDI-DIs·31 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
GB Lifecare Co., Ltd.
Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer
🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH
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
KET-1
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·No longer on the market
Contrex Plus III
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Apex Biotechnology Corp.·On the market
GlucoSure Autocode
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Apex Biotechnology Corp.·On the market
UASure II
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·4 countries
HemoSmart GOLD
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·3 countries
HemoSmart GOLD
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·3 countries
THE EDGE
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·6 countries
THE EDGE
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·6 countries
GLUCOSE TEST STRIPS
Device
EU IVDD
·
Eu Ivd Self Testing
·Changsha Sinocare Inc.·On the market