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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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5 device results listed.

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cTnI/CK-MB/Myo 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: 06950996047043
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DRHG
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-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: 06950996003865
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR10
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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/CK-MB/Myo 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: 06950996003872
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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

cTnI/CK-MB/Myo 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: 06950996037464
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR10LH
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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

cTnI/CK-MB/Myo 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: 06950996061698
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DRLH
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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