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EUDAMED Device Search

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

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07.07.2026 08:54

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06974541565479

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565479
Basic UDI-DI: B-06974541565479
Reference: ICA2230
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Slovakia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565462

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565462
Basic UDI-DI: B-06974541565462
Reference: ICA2230
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Slovakia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565455

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565455
Basic UDI-DI: B-06974541565455
Reference: ICA2230
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565448

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565448
Basic UDI-DI: B-06974541565448
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565431

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565431
Basic UDI-DI: B-06974541565431
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Ireland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565424

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565424
Basic UDI-DI: B-06974541565424
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Poland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565417

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565417
Basic UDI-DI: B-06974541565417
Reference: ICA2229
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Denmark
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565400

20 tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565400
Basic UDI-DI: B-06974541565400
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565394

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565394
Basic UDI-DI: B-06974541565394
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Hungary
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565387

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565387
Basic UDI-DI: B-06974541565387
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565370

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565370
Basic UDI-DI: B-06974541565370
Reference: ICA2225
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461076
Basic UDI-DI: B-06974246461076
Reference: FCRA-6052
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

High Risk Human Papillomavirus (HPV) Genotyping System

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149074
Basic UDI-DI: B-06973873149074
Reference: HPVS02
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Portugal
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

06972947800224

100pcs/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Qankorey Biotechnology Company Ltd.
Manufacturer SRN: CN-MF-000048769
UDI-DI: 06972947800224
Basic UDI-DI: B-06972947800224
Reference: 0302015
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 16:12

Manufacturer products Authorised representative products Authorised representative actors View details

06972947800026

1pcs/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Qankorey Biotechnology Company Ltd.
Manufacturer SRN: CN-MF-000048769
UDI-DI: 06972947800026
Basic UDI-DI: B-06972947800026
Reference: 302013
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 16:12

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Kinghawk Pharmaceutical CO., Ltd
Manufacturer SRN: CN-MF-000052726
UDI-DI: 06971140521349
Basic UDI-DI: B-06971140521349
Reference: 0201002636
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR)

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Kinghawk Pharmaceutical CO., Ltd
Manufacturer SRN: CN-MF-000052726
UDI-DI: 06971140521332
Basic UDI-DI: B-06971140521332
Reference: 0201002863
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR)

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Kinghawk Pharmaceutical CO., Ltd
Manufacturer SRN: CN-MF-000052726
UDI-DI: 06971140521325
Basic UDI-DI: B-06971140521325
Reference: 0201002862
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Kinghawk Pharmaceutical CO., Ltd
Manufacturer SRN: CN-MF-000052726
UDI-DI: 06971140521318
Basic UDI-DI: B-06971140521318
Reference: 0201002861
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Antibody Rapid Test Kit (Lateral Flow Immunoassay)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Kinghawk Pharmaceutical CO., Ltd
Manufacturer SRN: CN-MF-000052726
UDI-DI: 06971140521257
Basic UDI-DI: B-06971140521257
Reference: 0201002856
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details