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01.08.2026 13:11

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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

Cancer Antigen 125 (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685836
Basic UDI-DI: 69703416803205049JR
Reference: 0320500903
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
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

Carcinoembryonic Antigen (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685850
Basic UDI-DI: 69703416803205062JH
Reference: 0320500503
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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

pro-Gastrin-Releasing Peptide (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341686024
Basic UDI-DI: 69703416803205051JC
Reference: 0320501303
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
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

Squamous Cell Carcinoma (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341689230
Basic UDI-DI: 69703416803205050JA
Reference: 0320501203
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
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

DxPG80.Lab

DxPG80

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

Manufacturer: Progastrin Manufacturing
Manufacturer SRN: FR-MF-000011162
UDI-DI: 03760314550079
Basic UDI-DI: 376031455DXPG809R
Reference: DxL2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

MonoTotal® IRMA KIT

C52721

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590741693
Basic UDI-DI: 150995905C52721TJ
Reference: C52721
EMDN: W0102030126
EMDN description: CYTOKERATINS
First on market country: Czechia
Authorised representative: -
Last updated: 01.07.2026 11:58

Manufacturer products View details

TPS® IRMA kit

C52733

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590741716
Basic UDI-DI: 150995905C52733TR
Reference: C52733
EMDN: W0102030117
EMDN description: TUMOR POLYPEPTIDE ANTIGEN (TPA - INCL. TPS)
First on market country: Czechia
Authorised representative: -
Last updated: 01.07.2026 11:58

Manufacturer products View details

Access OV Monitor (Reagent Pack)

386357

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232382
Basic UDI-DI: 150995901AccOVMonRW
Reference: 386357
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Access BR Monitor (Reagent Pack)

387620

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231859
Basic UDI-DI: 150995901AccBRMonLK
Reference: 387620
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
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

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

Cancer Antigen 72-4 (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062846
Basic UDI-DI: 69703416803205052JE
Reference: 0320501703
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 (eCLIA)

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064376
Basic UDI-DI: 69703416803205087JZ
Reference: 0320509403
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Pro-gastrin-releasing peptide 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: 06978465237412
Basic UDI-DI: 697846523ProteinC09RV
Reference: 100 tests
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Pro-gastrin-releasing peptide 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: 06978465237405
Basic UDI-DI: 697846523ProteinC09RV
Reference: 50 tests
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Pro-gastrin-releasing peptide 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: 06978465237399
Basic UDI-DI: 697846523ProteinC09RV
Reference: 25 tests
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 242 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: 06978465237382
Basic UDI-DI: 697846523ProteinC17RU
Reference: 100 tests
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 242 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: 06978465237375
Basic UDI-DI: 697846523ProteinC17RU
Reference: 50 tests
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 242 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: 06978465237368
Basic UDI-DI: 697846523ProteinC17RU
Reference: 25 tests
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 50 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: 06978465237351
Basic UDI-DI: 697846523ProteinC16RS
Reference: 100 tests
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details