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135 device results listed.

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CA19-9 Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702682
Basic UDI-DI: B-06954414702682
Reference: /
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334817932
Basic UDI-DI: B-06950334817932
Reference: 52026130
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

DiaRapid CA19-9 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598212479
Basic UDI-DI: B-06942598212479
Reference: S199-402
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

06941967231066

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231066
Basic UDI-DI: B-06941967231066
Reference: 0601701
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CA 19-9

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404489
Basic UDI-DI: 69713904301067K
Reference: 010106601
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300353

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300353
Basic UDI-DI: B-06937287300353
Reference: 100 tests/kit
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751260
Basic UDI-DI: B-06936595751260
Reference: FG1202Y
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)

IVD Class CNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794589446
Basic UDI-DI: 69257945W0102030103R0LV
Reference: 3021015
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 24.06.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)

IVD Class CNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794589453
Basic UDI-DI: 69257945W0102030103R0LV
Reference: 3021076
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 24.06.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Rapid Quantitative Test (Chemiluminescence Immunoassay)