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206 device results listed.

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VIDAS® AFP

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064990
Basic UDI-DI: 357302BUDI000236T9
Reference: 30413
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

Access AFP (100 & 200 Test)(Reagent Pack)

33210

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231507
Basic UDI-DI: 150995901AccAFPLW
Reference: 33210
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP (300 & 600 Test Kit)

33211

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231491
Basic UDI-DI: 150995901AccAFP300PR
Reference: 33211
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP Sample Diluent

33216

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231477
Basic UDI-DI: 150995901AccAFPSamDilDU
Reference: 33216
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® AFP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200479
Basic UDI-DI: B-08056771200479
Reference: 314471
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

IMMULITE 2000 AFP

IVDR_67_LLB_DUB-C_C_KIT_AFP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961040
Basic UDI-DI: 0405686901440VA
Reference: 10381184
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 AFP

IVDR_67_LLB_DUB-C_C_KIT_AFP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961033
Basic UDI-DI: 0405686901440VA
Reference: 10381187
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Rapid Test Device

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304176
Basic UDI-DI: B-69743840304176
Reference: 3040401
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® AFP

IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177328
Basic UDI-DI: 0405686901798WQ
Reference: 10309979
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-484H

Alpha-fetoprotein Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-484H
Basic UDI-DI: B-TD-HNKX-CED-484H
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK001D8
Basic UDI-DI: B-SEK001D8
Reference: SE-K001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022030E7
Basic UDI-DI: B-SAC2022030E7
Reference: SAC2022030
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022029EN
Basic UDI-DI: B-SAC2022029EN
Reference: SAC2022029
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022028EL
Basic UDI-DI: B-SAC2022028EL
Reference: SAC2022028
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022007EC
Basic UDI-DI: B-SAC2022007EC
Reference: SAC2022007
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

INNODX AFP CMIA

KR-AFP-01100C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-AFP-01100CPX
Basic UDI-DI: B-KR-AFP-01100CPX
Reference: KR-AFP-01100C
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-032PA

Alpha-fetoprotein (AFP) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-032PA
Basic UDI-DI: B-K90411-032PA
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD189Y8
Basic UDI-DI: B-GKPD189Y8
Reference: GKPD189
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

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

GEAFP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEAFP-402aUZ
Basic UDI-DI: B-GEAFP-402aUZ
Reference: GEAFP-402a
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 Cassette (Whole Blood/Serum/Plasma)

GEAFP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEAFP-402aHGS3
Basic UDI-DI: B-GEAFP-402aHGS3
Reference: GEAFP-402a
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