108 results
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11ms
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Sources: EU EUDAMED, US FDA
AFP FIA
Device
EU IVDD
·
Eu Ivd General
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
Daan Gene Co., Ltd.
Manufacturer
🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
AFP FIA Kit
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
Hangzhou Realy Tech Co.,Ltd.
Manufacturer
🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
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.
AFP Test Kit (FIA)
Device
EU IVDD
·
Eu Ivd General
·Guangdong Wesail Biotech Co., Ltd.·On the market
Rapid AFP Test Card
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
AFP Rapid Quantitative Test
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Alpha-Fetoprotein (AFP) Rapid Test
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Immuno Biotech Co., Ltd·On the market
CEA/AFP Rapid Quantitative Test
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer
🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.
Suny (Xiamen) Biotechnology Co., Ltd.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·CeCert Sp. z o.o.
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer
🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.
Alpha-fetoprotein (AFP) Assay Reagent Kit (CMIA)
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Realy Tech Co.,Ltd.·On the market
Zhongshan Bio-Tech Co., Ltd.
Manufacturer
🇨🇳 China·24 Basic UDI-DIs·24 Devices·CeCert Sp. z o.o. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.