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227 device results listed.

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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-CNM0000180729002NP

9002C

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180729002NP
Basic UDI-DI: B-CNM0000180729002NP
Reference: 9002C
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors 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

biotical FOB Card ( +PC +NC)

biotical FOB Card ( +PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo FOB +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942141894
Basic UDI-DI: B-84365942141894
Reference: RTB25FCN
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:01

Manufacturer products View details

biotical FOB Card (+PC)

biotical FOB Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo FOB)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942141726
Basic UDI-DI: B-84365942141726
Reference: RTB25FC
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:01

Manufacturer products View details

biotical FOB Card

biotical FOB Card / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942141658
Basic UDI-DI: B-84365942141658
Reference: RTB25F
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:01

Manufacturer products 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

D-808052-1AL

FOB 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-808052-1AL
Basic UDI-DI: B-808052-1AL
Reference: 808052-1
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

PROFAR Test PSA

PROFAR TEST PSA

IVD Annex II List BIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-801080NW
Basic UDI-DI: B-801080NW
Reference: 801080
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

PROFAR TEST COLON RETTO

Profar Test Colon Retto

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-801040NJ
Basic UDI-DI: B-801040NJ
Reference: 801040
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

800040-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800040-1CS2T
Basic UDI-DI: B-800040-1CS2T
Reference: 800040-1CS
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

CEA Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245295
Basic UDI-DI: B-15065026245295
Reference: TV20042
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details