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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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01.08.2026 01:12

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Active filter:EMDN:W0105010111

6 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

+ENTIRE5702109

Chlamydia trachomatis IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE5702109
Basic UDI-DI: B-+ENTIRE5702109
Reference: RE57021
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

Manufacturer products View details

+ENTIEIA-381101

Chlamydia trachomatis IgM ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-381101
Basic UDI-DI: B-+ENTIEIA-381101
Reference: EIA-3811
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTICHLM0070DS0U

NovaLisa® Chlamydia trachomatis IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICHLM0070DS0U
Basic UDI-DI: B-+ENTICHLM0070DS0U
Reference: CHLM0070DS
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICHLM00700W

NovaLisa® Chlamydia trachomatis IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICHLM00700W
Basic UDI-DI: B-+ENTICHLM00700W
Reference: CHLM0070
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

Infectious Mononucleosis Igm Rapid Test Device(Whole Blood/Serum/Plasma)

A410501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475621
Basic UDI-DI: B-06976753475621
Reference: A410501D
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details