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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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21.09.2026 09:42

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Active filter:Manufacturer SRN:CN-MF-000007517

106 device results listed.

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06974541565493

Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565493
Basic UDI-DI: B-06974541565493
Reference: PR2024-UT01
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565684

24 samples/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565684
Basic UDI-DI: B-06974541565684
Reference: PR2026-HP04
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565677

8 samples/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565677
Basic UDI-DI: B-06974541565677
Reference: PR2026-HP04
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Cyprus
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565639

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565639
Basic UDI-DI: B-06974541565639
Reference: ICA2114-11
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565622

1 test/kit

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565622
Basic UDI-DI: B-06974541565622
Reference: ICA2114-11
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565615

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565615
Basic UDI-DI: B-06974541565615
Reference: ICA2508
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565608

1 Test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565608
Basic UDI-DI: B-06974541565608
Reference: ICA2508
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - 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

06974541565561

1 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565561
Basic UDI-DI: B-06974541565561
Reference: ICA2521
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - 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

06974541565578

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565578
Basic UDI-DI: B-06974541565578
Reference: ICA2521
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - 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

06974541565530

1 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565530
Basic UDI-DI: B-06974541565530
Reference: ICA2501
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - 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

06974541565554

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565554
Basic UDI-DI: B-06974541565554
Reference: ICA2501
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Belgium
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565523

5 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565523
Basic UDI-DI: B-06974541565523
Reference: ICA2235
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565516

1 Test/Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565516
Basic UDI-DI: B-06974541565516
Reference: ICA2235
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
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

06974541565509

24 samples/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565509
Basic UDI-DI: B-06974541565509
Reference: PR2024-UT01
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
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

06974541565486

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565486
Basic UDI-DI: B-06974541565486
Reference: ICA2230
EMDN: W0102160304
EMDN description: LH - 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

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