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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

01.08.2026 18:27

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63 device results listed.

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HOKAPI™ CA 50

HOKAPI™ CA 50

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404519
Basic UDI-DI: 69713904301087P
Reference: 010108001
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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

Carbohydrate Antigen 50 (CLIA)

105-010090-00、105-010100-00、105-010140-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908096
Basic UDI-DI: 69449040004V-CA50******UL
Reference: 105-010090-00
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

-

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

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

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: 06978465237344
Basic UDI-DI: 697846523ProteinC16RS
Reference: 50 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

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: 06978465237337
Basic UDI-DI: 697846523ProteinC16RS
Reference: 25 tests
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:25

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: 06978465234107
Basic UDI-DI: 697846523ProteinC16RS
Reference: 2×50 test
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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 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: 06978465234053
Basic UDI-DI: 697846523ProteinC16RS
Reference: 2×100 test
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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 50

HOKAPI™ CA 50

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: 06971390439647
Basic UDI-DI: 69713904301087P
Reference: 010108101
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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 50 (CA50) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522641743
Basic UDI-DI: B-06970522641743
Reference: DD1801
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:45

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL CA50 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798265
Basic UDI-DI: B-06954414798265
Reference: /
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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

CA50 CLIA Microparticles

CA50 CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359508896
Basic UDI-DI: 697015090000225HA
Reference: CMB0410
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 50 CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590216
Basic UDI-DI: 697518250F12204ZW
Reference: F12204
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231424
Basic UDI-DI: B-06941967231424
Reference: 0603501
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CA 50

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404526
Basic UDI-DI: 69713904301087P
Reference: 010108601
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300674
Basic UDI-DI: B-06937287300674
Reference: 100 tests/kit
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 Kit (CLIA)

-

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751277
Basic UDI-DI: B-06936595751277
Reference: FG1205Y
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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

Carbohydrate Antigen 50 (CLIA)

-

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908140
Basic UDI-DI: 69449040004V-CA50******UL
Reference: 105-010100-00
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 16:24

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207268
Basic UDI-DI: B-06933260207268
Reference: BT0505805
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207251
Basic UDI-DI: B-06933260207251
Reference: BT0505804
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details