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50 device results listed.

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Alpha Fetal Protein FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646AFP001FJB3E
Basic UDI-DI: B-697424646AFP001FJB3E
Reference: AFP-3012F
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha Fetal Protein FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646AFP000FJ82M
Basic UDI-DI: B-697424646AFP000FJ82M
Reference: AFP-4012F
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Embryo Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5C02C1UY
Basic UDI-DI: B-5C02C1UY
Reference: 5C02C1-25-EU, 5C02C1-50-EU
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5C01C1UT
Basic UDI-DI: B-5C01C1UT
Reference: 5C01C1-25-EU, 5C01C1-50-EU
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251876
Basic UDI-DI: B-06976232251876
Reference: CA05-07-422P25
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

SERATEC PSA Semiquant TM

IVD Annex II List BIVDDOn the marketProfessional testingSingle use

Manufacturer: SERATEC Gesellschaft für Biotechnologie mbH
Manufacturer SRN: DE-MF-000031456
UDI-DI: D-DE-MF000031456MB
Basic UDI-DI: B-DE-MF000031456MB
Reference: PSM400T
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 13.07.2026 16:24

Manufacturer products View details

D-CEA-W23NJ

Carcinoembryonic Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-CEA-W23NJ
Basic UDI-DI: B-CEA-W23NJ
Reference: CEA-W23
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CEA-D06a3P
Basic UDI-DI: B-CEA-D06a3P
Reference: CEA-D06a
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-AFP-D06a95
Basic UDI-DI: B-AFP-D06a95
Reference: AFP-D06a
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 12.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Test Kit(Feces)

FOB0073

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610405
Basic UDI-DI: B-86979834610405
Reference: FOB0073
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-808123-1AF

CA12-5 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808123-1AF
Basic UDI-DI: B-808123-1AF
Reference: 808123-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808110-19R

AFP Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808110-19R
Basic UDI-DI: B-808110-19R
Reference: 808110-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808086-1BV

CA19-9 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808086-1BV
Basic UDI-DI: B-808086-1BV
Reference: 808086-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808085-1BQ

CA15-3 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808085-1BQ
Basic UDI-DI: B-808085-1BQ
Reference: 808085-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808073-1B7

CEA Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808073-1B7
Basic UDI-DI: B-808073-1B7
Reference: 808073-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808072QG

β-HCG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808072QG
Basic UDI-DI: B-808072QG
Reference: 808072
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

FOB-TRF Combo Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763259
Basic UDI-DI: B-15065023763259
Reference: TV10026
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142646

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142646
Basic UDI-DI: B-06977194142646
Reference: HR0531003
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142639

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142639
Basic UDI-DI: B-06977194142639
Reference: HR0531002
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142622

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142622
Basic UDI-DI: B-06977194142622
Reference: HR0531001
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details