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115 device results listed.

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Carbohydrate Antigen 19-9 (CLIA)

IVD Class CNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047928
Basic UDI-DI: 69449040004H-CA19-9****M7
Reference: 105-004244-00
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Calibrators

IVD Class CNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048277
Basic UDI-DI: 69449040004H-CA19-9****M7
Reference: 105-004286-00
EMDN: W0102030103
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

03770024321111

ELSA-CA19-9

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321111
Basic UDI-DI: B-03770024321111
Reference: ELSA-CA19-9
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ichroma™ CA19-9

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043837
Basic UDI-DI: 880613300130BH
Reference: CFPC-139
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CA 19-9

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404472
Basic UDI-DI: 69713904301067K
Reference: 010106001
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

Carbonhydrate Antigen 19-9 (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685812
Basic UDI-DI: 69703416803205024J9
Reference: 0320500803
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Access GI Monitor (Reagent Pack)

387687

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231842
Basic UDI-DI: 150995901AccGIMonLB
Reference: 387687
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465237320
Basic UDI-DI: 697846523ProteinC06RP
Reference: 100 tests
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465237313
Basic UDI-DI: 697846523ProteinC06RP
Reference: 50 tests
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465237306
Basic UDI-DI: 697846523ProteinC06RP
Reference: 25 tests
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465234008
Basic UDI-DI: 697846523ProteinC06RP
Reference: 2×50 test
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465233957
Basic UDI-DI: 697846523ProteinC06RP
Reference: 2×100 test
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CA 19-9

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439623
Basic UDI-DI: 69713904301067K
Reference: 010106101
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:01

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522645505
Basic UDI-DI: B-06970522645505
Reference: DD1101
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908348
Basic UDI-DI: 697015090000010GK
Reference: CMB0802
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

IRMA CA 19-9 antigen

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590666316
Basic UDI-DI: 150995905CA19-9IRMARN
Reference: IM3151, B64313
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:49

Manufacturer products View details

Carbohydrate antigen 19-9 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701243
Basic UDI-DI: B-06955792701243
Reference: S2107E-24
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate antigen 19-9 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701236
Basic UDI-DI: B-06955792701236
Reference: S2107E-48
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Getein

MAGICL CA19-9 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798258
Basic UDI-DI: B-06954414798258
Reference: /
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

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