Public EUDAMED Search

EUDAMED Device Search

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

Last updated

14.10.2026 22:56

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Device

4147012

Actor

48061

Certificate

3479

Active filter:Certificate number:6188440TD05

3 device results listed.

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β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996066884
Basic UDI-DI
69509960FAHCG-402a-DRAR
Reference
FAHCG-402a-DRHG
EMDN
W0102160302
EMDN description
HCG - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
13.10.2026 10:35
β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003926
Basic UDI-DI
69509960FAHCG-402a-DRAR
Reference
FAHCG-402a-DR10
EMDN
W0102160302
EMDN description
HCG - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:49
IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003933
Basic UDI-DI
69509960FAHCG-402a-DRAR
Reference
FAHCG-402a-DR
EMDN
W0102160302
EMDN description
HCG - RT & POC
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47