- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Manufacturer SRN
- CN-MF-000014156
- UDI-DI
- 06944904047898
- Basic UDI-DI
- 69449040AB74000225E
- Reference
- 105-004241-00
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 06.07.2026 05:10
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
21.09.2026 20:20
Sync status
Successful
Device
3158146
Actor
47652
Certificate
3295
IVD Class CNot specifiedOn the marketHuman tissuesKitProfessional testingReagent
IVD Class CNot specifiedOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Manufacturer SRN
- CN-MF-000014156
- UDI-DI
- 06944904048246
- Basic UDI-DI
- 69449040AB74000225E
- Reference
- 105-004283-00
- EMDN
- W0102039001
- EMDN description
- TUMOUR MARKER STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 06.07.2026 05:10
RG-AFP
OCFA07-AFP
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Cisbio Bioassays
- Manufacturer SRN
- FR-MF-000024051
- UDI-DI
- 03770024321340
- Basic UDI-DI
- B-03770024321340
- Reference
- OCFA07-AFP
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- France
- Authorised representative
- -
- Last updated
- 05.07.2026 22:32
03770024321098
ELSA2-AFP
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Cisbio Bioassays
- Manufacturer SRN
- FR-MF-000024051
- UDI-DI
- 03770024321098
- Basic UDI-DI
- B-03770024321098
- Reference
- ELSA2-AFP
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- France
- Authorised representative
- -
- Last updated
- 05.07.2026 22:31
AFP Test Kit (Fluorescence Immunoassay)
AFP Test Kit (Fluorescence Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- Manufacturer SRN
- CN-MF-000012807
- UDI-DI
- D-000012807185066R4
- Basic UDI-DI
- B-000012807185066R4
- Reference
- HWTS-OT111
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 04.07.2026 08:59
ichroma™ AFP Neo
ichroma™ AFP Neo
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133044216
- Basic UDI-DI
- 880613300123BL
- Reference
- CFPC-156
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Greece
- Authorised representative
- Obelis s.a.
- Last updated
- 03.07.2026 20:39
HOKAPI™ AFP
HOKAPI™ AFP
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- Manufacturer SRN
- CN-MF-000013723
- UDI-DI
- 06939716404397
- Basic UDI-DI
- 69713904301027B
- Reference
- 010102001
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- France
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 11:54
06935740732789
Alpha-fetoprotein (AFP)Assay Kit (Chemiluminescent Microparticle Immunoassay)
IVD Class CIVDR 2017/746On the marketProfessional testingReagent
- Manufacturer
- URIT Medical Electronic Co.,Ltd.
- Manufacturer SRN
- CN-MF-000011840
- UDI-DI
- 06935740732789
- Basic UDI-DI
- 69357407IIAS000016F7
- Reference
- USIA00000168M
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 10:04
Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
25 tests,50 tests,2×50 tests,100 tests,2×100 tests
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen Dake Medical Technology Co.,Ltd
- Manufacturer SRN
- CN-MF-000047336
- UDI-DI
- 06978465238136
- Basic UDI-DI
- 697846523TumorC019V
- Reference
- 100 tests
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Austria
- Authorised representative
- HyperCert Limited B.V.
- Last updated
- 30.06.2026 12:29
Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
25 tests,50 tests,2×50 tests,100 tests,2×100 tests
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen Dake Medical Technology Co.,Ltd
- Manufacturer SRN
- CN-MF-000047336
- UDI-DI
- 06978465238129
- Basic UDI-DI
- 697846523TumorC019V
- Reference
- 50 tests
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Austria
- Authorised representative
- HyperCert Limited B.V.
- Last updated
- 30.06.2026 12:29
Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
25 tests,50 tests,2×50 tests,100 tests,2×100 tests
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen Dake Medical Technology Co.,Ltd
- Manufacturer SRN
- CN-MF-000047336
- UDI-DI
- 06978465238112
- Basic UDI-DI
- 697846523TumorC019V
- Reference
- 25 tests
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Austria
- Authorised representative
- HyperCert Limited B.V.
- Last updated
- 30.06.2026 12:29
Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
25 tests,50 tests,2×50 tests,100 tests,2×100 tests
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen Dake Medical Technology Co.,Ltd
- Manufacturer SRN
- CN-MF-000047336
- UDI-DI
- 06978465234640
- Basic UDI-DI
- 697846523TumorC019V
- Reference
- 2×50 test
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Austria
- Authorised representative
- HyperCert Limited B.V.
- Last updated
- 30.06.2026 12:22
Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
25 tests,50 tests,2×50 tests,100 tests,2×100 tests
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen Dake Medical Technology Co.,Ltd
- Manufacturer SRN
- CN-MF-000047336
- UDI-DI
- 06978465230154
- Basic UDI-DI
- 697846523TumorC019V
- Reference
- 2×100 test
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Austria
- Authorised representative
- HyperCert Limited B.V.
- Last updated
- 30.06.2026 12:20
HOKAPI™ AFP
HOKAPI™ AFP
IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent
- Manufacturer
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- Manufacturer SRN
- CN-MF-000013723
- UDI-DI
- 06971390439609
- Basic UDI-DI
- 69713904301027B
- Reference
- 010102101
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- France
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 30.06.2026 12:01
Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)
2×50 test/box Calibrator:0.5mL×2
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000003026
- UDI-DI
- 06970522641057
- Basic UDI-DI
- B-06970522641057
- Reference
- DD0101
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 30.06.2026 04:45
AFP CLIA Microparticles
AutoLumo analyzer
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- Manufacturer SRN
- CN-MF-000003348
- UDI-DI
- 06970150908270
- Basic UDI-DI
- 697015090000006GU
- Reference
- CMB0102
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Italy
- Authorised representative
- QbD RepS BV
- Last updated
- 29.06.2026 22:47
AFP CLIA Microparticles
AutoLumo analyzer
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- Manufacturer SRN
- CN-MF-000003348
- UDI-DI
- 06970150905194
- Basic UDI-DI
- 697015090000006GU
- Reference
- CMB0101
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Italy
- Authorised representative
- QbD RepS BV
- Last updated
- 29.06.2026 22:45
IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
- Manufacturer
- Beckman Coulter Inc.
- Manufacturer SRN
- US-MF-000010288
- UDI-DI
- 15099590701697
- Basic UDI-DI
- 150995901AccAFPLW
- Reference
- C22847
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- -
- Authorised representative
- Beckman Coulter Ireland Inc.
- Last updated
- 29.06.2026 13:49
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Beckman Coulter Inc.
- Manufacturer SRN
- US-MF-000010288
- UDI-DI
- 15099590744403
- Basic UDI-DI
- 150995901AccAFP300PR
- Reference
- C28649
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- -
- Authorised representative
- Beckman Coulter Ireland Inc.
- Last updated
- 29.06.2026 13:40
Getein
MAGICL AFP-L3 (CLIA)
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Getein Biotech, Inc.
- Manufacturer SRN
- CN-MF-000017986
- UDI-DI
- 06954414798678
- Basic UDI-DI
- B-06954414798678
- Reference
- /
- EMDN
- W0102039001
- EMDN description
- ALPHAFETOPROTEIN
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 28.06.2026 18:34