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Access CEA (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33200FE
Basic UDI-DI: B-33200FE
Reference: 33200
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-3306U

Cyfra21-1 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-3306U
Basic UDI-DI: B-3306U
Reference: /
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-32879

Cancer Antigen 15-3 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-32879
Basic UDI-DI: B-32879
Reference: /
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-3066X

Carbohydrate Antigen 19-9 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-3066X
Basic UDI-DI: B-3066X
Reference: /
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-3036R

Carcinoembryonic Antigen 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-3036R
Basic UDI-DI: B-3036R
Reference: /
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-3026P

Cancer Antigen 125 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-3026P
Basic UDI-DI: B-3026P
Reference: /
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
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

Carcinoembryonic Antigen Test Kit (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346328
Basic UDI-DI: B-20850076346328
Reference: CECEA-301a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

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