18 results · 16ms · Sources: EU EUDAMED, US FDA

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Sharay CEA (CLIA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·1 device

CEA Rapid Quantitative Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

CEA/AFP Rapid Quantitative Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

EMSRUN GROUP

Manufacturer
🇨🇳 China·12 Basic UDI-DIs·50 Devices·1 Importer·TÜV Rheinland LGA Products GmbH

Abiores Technology (Beijing) Co.,Ltd.

Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·3 Importers·TÜV Rheinland LGA Products GmbH

Be Sure HCG-Schwangerschafts-Frühtest

Device
EU IVDD · Eu Ivd Self Testing ·Abiores Technology (Beijing) Co.,Ltd.·On the market

BE SURE Early HCG Pregnancy Test

Device
EU IVDD · Eu Ivd Self Testing ·Abiores Technology (Beijing) Co.,Ltd.·On the market

Be Sure HCG-Schwangerschafts-Frühtest

Device
EU IVDD · Eu Ivd Self Testing ·Abiores Technology (Beijing) Co.,Ltd.·On the market

HCG Pregnancy Tests

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Abiores Technology (Beijing) Co.,Ltd.·1 device

HCG Pregnancy Tests

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Abiores Technology (Beijing) Co.,Ltd.·1 device

HCG Pregnancy Tests

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Abiores Technology (Beijing) Co.,Ltd.·1 device

HL 2057387-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·Abiores Technology (Beijing) Co.,Ltd.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs

HZ 2502508-1

Certificate
MDR QMS·EMSRUN GROUP·TÜV Rheinland LGA Products GmbH