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115 device results listed.

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D-6-81AL

Cancer Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-81AL
Basic UDI-DI: B-6-81AL
Reference: "REF: USIA00000133M, USIA00000134M"
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS CA19-9

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043875
Basic UDI-DI: 880613300639CU
Reference: SMFP-134
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

CA 19-9 AccuBind ELISA Kit - 96 wells

3925-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020518
Basic UDI-DI: 081687002CA1993925VC
Reference: 3925-300A
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 GI-MA

IVDR_67_LLB_DUB-C_C_KIT_GI-MA

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961545
Basic UDI-DI: 0405686901452VH
Reference: 10380988
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® CA 19-9™

IVDR_67_TTN_DUB-C_C_KIT_CA 19-9

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414574028
Basic UDI-DI: 0405686900806VP
Reference: 10491244
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 19-9 (CA19-9)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598161
Basic UDI-DI: 0405686900806VP
Reference: 10995489
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 19-9 (CA19-9)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598178
Basic UDI-DI: 0405686900806VP
Reference: 10995490
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Test Kit (FIA)

VID57

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID573C
Basic UDI-DI: B-VID573C
Reference: VID57-06-011
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-674M

Carbohydrate Antigen 19-9 Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-674M
Basic UDI-DI: B-TD-HNKX-CED-674M
Reference: /
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK003DC
Basic UDI-DI: B-SEK003DC
Reference: SE-K003
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA19-9 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA19-9-01100CB5
Basic UDI-DI: B-KR-CA19-9-01100CB5
Reference: KR-CA19-9-01100C
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD187Y4
Basic UDI-DI: B-GKPD187Y4
Reference: GKPD187
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA19-9

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76427G3
Basic UDI-DI: B-DC76427G3
Reference: DC76427
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA19-9

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76426FZ
Basic UDI-DI: B-DC76426FZ
Reference: DC76426
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA19-9

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76425FX
Basic UDI-DI: B-DC76425FX
Reference: DC76425
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA19-9

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76424FV
Basic UDI-DI: B-DC76424FV
Reference: DC76424
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA 19-9

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76041F9
Basic UDI-DI: B-DC76041F9
Reference: DC76041
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C04DJ
Basic UDI-DI: B-7C04DJ
Reference: 7C04V1-B-EU, 7C04U1-B-EU, 7C04P1-B-EU
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

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

Carbohydrate Antigen 19-9 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346335
Basic UDI-DI: B-20850076346335
Reference: CECA199-301a
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details