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

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01.08.2026 13:11

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63 device results listed.

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Human Epididymal Protein 4 (CLIA)

105-010088-00、 105-010098-00、105-010138-00

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: 06936415908072
Basic UDI-DI: 69449040004V-HE4*******Y8
Reference: 105-010088-00
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

Human Epididymis Protein 4 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: 06978465235845
Basic UDI-DI: 697846523ProteinC08RT
Reference: 2×100 test
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 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: 06978465235838
Basic UDI-DI: 697846523ProteinC08RT
Reference: 100 tests
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 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: 06978465235821
Basic UDI-DI: 697846523ProteinC08RT
Reference: 2×50 test
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 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: 06978465235814
Basic UDI-DI: 697846523ProteinC08RT
Reference: 50 tests
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 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: 06978465235807
Basic UDI-DI: 697846523ProteinC08RT
Reference: 25 tests
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HE4

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: 06971390439708
Basic UDI-DI: 69713904301147J
Reference: 010114101
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymal Protein 4 (HE4) 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: 06970522646205
Basic UDI-DI: B-06970522646205
Reference: DD0601
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

Human epididymal protein 4 Assay Kit (Chemiluminescent Immunoassay)

Human epididymal protein 4 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701229
Basic UDI-DI: B-06955792701229
Reference: S2115E-24
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

Human epididymal protein 4 Assay Kit (Chemiluminescent Immunoassay)

Human epididymal protein 4 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701212
Basic UDI-DI: B-06955792701212
Reference: S2115E-48
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL HE4 (CLIA)

MAGICL HE4 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798357
Basic UDI-DI: B-06954414798357
Reference: /
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

HE4 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: 06942359508995
Basic UDI-DI: 697015090000227HE
Reference: CMB1810
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

Human Epididymis Protein 4 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: 06942293590803
Basic UDI-DI: 697518250F122092B
Reference: F12209
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231486
Basic UDI-DI: B-06941967231486
Reference: 0603801
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404649
Basic UDI-DI: 69713904301147J
Reference: 010114601
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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: 06937287300360
Basic UDI-DI: B-06937287300360
Reference: 100 tests/kit
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymal Protein 4 Kit (CLIA)

-

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751369
Basic UDI-DI: B-06936595751369
Reference: FG1214Y
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

Human Epididymal Protein 4（CLIA）

-

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908126
Basic UDI-DI: 69449040004V-HE4*******Y8
Reference: 105-010098-00
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

HE4 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: 06933260207510
Basic UDI-DI: B-06933260207510
Reference: BT0506505
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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

HE4 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: 06933260207503
Basic UDI-DI: B-06933260207503
Reference: BT0506504
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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