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206 device results listed.

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Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)

GEAFP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEAFP-401aUW
Basic UDI-DI: B-GEAFP-401aUW
Reference: GEAFP-401a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)

GEAFP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEAFP-401aHGRU
Basic UDI-DI: B-GEAFP-401aHGRU
Reference: GEAFP-401a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Quantitative Test Kit (Time-Resolved FIA)

FEAFP-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEAFP-302aTV
Basic UDI-DI: B-FEAFP-302aTV
Reference: FEAFP-302a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Quantitative Test Kit (Time-Resolved FIA)

FEAFP-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEAFP-302aHGQH
Basic UDI-DI: B-FEAFP-302aHGQH
Reference: FEAFP-302a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-AFP

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01897Z
Basic UDI-DI: B-DT01897Z
Reference: DT0189
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-AFP

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01907J
Basic UDI-DI: B-DT01907J
Reference: DT0190
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AFP

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76403FM
Basic UDI-DI: B-DC76403FM
Reference: DC76403
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AFP

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76402FK
Basic UDI-DI: B-DC76402FK
Reference: DC76402
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AFP

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76401FH
Basic UDI-DI: B-DC76401FH
Reference: DC76401
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AFP

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76400FF
Basic UDI-DI: B-DC76400FF
Reference: DC76400
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-AFP

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76042FB
Basic UDI-DI: B-DC76042FB
Reference: DC76042
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-D-AFP-42XM

Alpha-fetoprotein Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-D-AFP-42XM
Basic UDI-DI: B-D-AFP-42XM
Reference: D-AFP-42
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Alpha-Fetoprotein (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-AFP706-AERQ
Basic UDI-DI: B-AFP706-AERQ
Reference: AFP706-AE10Y, AFP706-AE10N, AFP706-AE20Y, AFP706-AE20N
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-AFP-02-48tAE
Basic UDI-DI: B-AFP-02-48tAE
Reference: AFP-02-48t
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 12.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C01DC
Basic UDI-DI: B-7C01DC
Reference: 7C01V1-B-EU, 7C01U1-B-EU, 7C01P1-B-EU
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-3016M

Alpha1-fetoprotein Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3016M
Basic UDI-DI: B-3016M
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346311
Basic UDI-DI: B-20850076346311
Reference: CEAFP-301a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-AFP

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723103
Basic UDI-DI: 692591270022GT
Reference: C86003-S
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

CanAg AFP EIA

600-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140371
Basic UDI-DI: B-17350066140371
Reference: 600-10
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

TruVue

AFP Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763655
Basic UDI-DI: B-15065023763655
Reference: TV20027
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details