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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

iStar-CA15-3

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76040F7
Basic UDI-DI: B-DC76040F7
Reference: DC76040
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
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

iStar-CA125

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76039FN
Basic UDI-DI: B-DC76039FN
Reference: DC76039
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
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

iStar-CEA

30 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76038FL
Basic UDI-DI: B-DC76038FL
Reference: DC76038
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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

CYFRA21-1 Cytokeratin 19 Fragments (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CY21-1706-AEMQ
Basic UDI-DI: B-CY21-1706-AEMQ
Reference: CY21-1706-AE10Y, CY21-1706-AE10N, CY21-1706-AE20Y, CY21-1706-AE20N
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Carcinoembryonic Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CEA706-AEJL
Basic UDI-DI: B-CEA706-AEJL
Reference: CEA706-AE10Y, CEA706-AE10N, CEA706-AE20Y, CEA706-AE20N
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

CA72-4 Cancer Antigen 72-4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA72-4706-AE5B
Basic UDI-DI: B-CA72-4706-AE5B
Reference: CA72-4706-AE10Y, CA72-4706-AE10N, CA72-4706-AE20Y, CA72-4706-AE20N
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 Cancer Antigen 50 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA50706-AETU
Basic UDI-DI: B-CA50706-AETU
Reference: CA50706-AE10Y, CA50706-AE10N, CA50706-AE20Y, CA50706-AE20N
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA242 Cancer Antigen 242 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA242706-AEEK
Basic UDI-DI: B-CA242706-AEEK
Reference: CA242706-AE10Y, CA242706-AE10N, CA242706-AE20Y, CA242706-AE20N
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Cancer Antigen 15-3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA15-3706-AEZE
Basic UDI-DI: B-CA15-3706-AEZE
Reference: CA15-3706-AE10Y, CA15-3706-AE10N, CA15-3706-AE20Y, CA15-3706-AE20N
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Cancer Antigen 125 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA125706-AEE9
Basic UDI-DI: B-CA125706-AEE9
Reference: CA125706-AE10Y, CA125706-AE10N, CA125706-AE20Y, CA125706-AE20N
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

Progastrin-Releasing Peptide assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C22DL
Basic UDI-DI: B-7C22DL
Reference: 7C22V1-B-EU, 7C22U1-B-EU, 7C22P1-B-EU
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C21DJ
Basic UDI-DI: B-7C21DJ
Reference: 7C21V1-B-EU, 7C21U1-B-EU, 7C21P1-B-EU
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
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

Carbohydrate Antigen 242 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C20DG
Basic UDI-DI: B-7C20DG
Reference: 7C20V1-B-EU, 7C20U1-B-EU, 7C20P1-B-EU
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
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

Carbohydrate Antigen 72-4 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C15DP
Basic UDI-DI: B-7C15DP
Reference: 7C15V1-B-EU, 7C15U1-B-EU, 7C15P1-B-EU
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
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

Cytokeratin 19 Fragment 21-1 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C13DK
Basic UDI-DI: B-7C13DK
Reference: 7C13V1-B-EU, 7C13U1-B-EU, 7C13P1-B-EU
EMDN: W0102030111
EMDN description: CYFRA 21-1
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

Cancer Antigen 15-3 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C10DD
Basic UDI-DI: B-7C10DD
Reference: 7C10V1-B-EU, 7C10U1-B-EU, 7C10P1-B-EU
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
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

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

Cancer Antigen 125 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C03DG
Basic UDI-DI: B-7C03DG
Reference: 7C03V1-B-EU, 7C03U1-B-EU, 7C03P1-B-EU
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
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

Cancer Embryo Antigen assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C02DE
Basic UDI-DI: B-7C02DE
Reference: 7C02V1-B-EU, 7C02U1-B-EU, 7C02P1-B-EU
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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