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 22:16

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Active filter:Certificate number:6188440TD11

3 device results listed.

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TSH Quantitative Test Kit (Time-Resolved FIA)

FKTSH-402a-DR10, FKTSH-402a-DR, FKTSH-402a-DR10HG, FKTSH-402a-DRHG, FKTSH-402a-DR10LH, FKTSH-402a-DRLH

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
06950996003841
Basic UDI-DI
69509960FKTSH-402a-DRH9
Reference
FKTSH-402a-DR10
EMDN
W0102160903
EMDN description
THYROID-STIMULATING HORMONE - RT & POC
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:48
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
06950996003858
Basic UDI-DI
69509960FKTSH-402a-DRH9
Reference
FKTSH-402a-DR
EMDN
W0102160903
EMDN description
THYROID-STIMULATING HORMONE - RT & POC
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
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
06950996013130
Basic UDI-DI
69509960FKTSH-402a-DRH9
Reference
FKTSH-402a-DRHG
EMDN
W0102160903
EMDN description
THYROID-STIMULATING HORMONE - RT & POC
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47