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178 device results listed.

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Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969980205
Basic UDI-DI: B-06974969980205
Reference: 50 Tests/kit（DR1016-1）
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969980069
Basic UDI-DI: B-06974969980069
Reference: 100 Tests/kit（DR1016-2）
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha Fetoprotein (AFP) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854621091
Basic UDI-DI: B-06974854621091
Reference: P22059
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205225
Basic UDI-DI: B-06974738205225
Reference: IF19-01-40
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205218
Basic UDI-DI: B-06974738205218
Reference: IF19-01-20
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFP FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892114
Basic UDI-DI: B-06974674892114
Reference: 18-02-0041
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101455

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101455
Basic UDI-DI: B-06974671101455
Reference: DR-PS-A002
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101448

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101448
Basic UDI-DI: B-06974671101448
Reference: DR-PS-A001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100397

250 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100397
Basic UDI-DI: B-06974671100397
Reference: DR-CLIA-CM-B001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100380

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100380
Basic UDI-DI: B-06974671100380
Reference: DR-CLIA-CM-A001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100014

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100014
Basic UDI-DI: B-06974671100014
Reference: DR-CM-A001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:06

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (AFP) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524062360
Basic UDI-DI: B-06974524062360
Reference: HCLIA15139
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003243
Basic UDI-DI: B-06974521003243
Reference: SUPF034025
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:34

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001003
Basic UDI-DI: B-06974521001003
Reference: SUPM066072
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000990
Basic UDI-DI: B-06974521000990
Reference: SUPM066036
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974323014287

AFP rapid test cassette (Rare earth nano fluorescence immunochromatography)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323014287
Basic UDI-DI: B-06974323014287
Reference: IF001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974323014270

AFP rapid test cassette (Rare earth nano fluorescence immunochromatography)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323014270
Basic UDI-DI: B-06974323014270
Reference: IF001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974323014263

AFP rapid test cassette (Rare earth nano fluorescence immunochromatography)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323014263
Basic UDI-DI: B-06974323014263
Reference: IF001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: France
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (AFP) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910438
Basic UDI-DI: B-06974238910438
Reference: HAFP035
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

06973914383146

100 TEST/KIT （CALIBRATION 6×1）

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383146
Basic UDI-DI: B-06973914383146
Reference: H201.02.021C2.610
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details