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EUDAMED Device Search

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

Last updated

23.09.2026 23:47

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3 device results listed.

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cTnI Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996055918
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DRHG
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003889
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DR10
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003896
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DR
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details