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Free Thyroxine Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3013782Model 2×50 Tests/kitRef 3013781Model 1×50 Tests/kitRef 3008734Model 1×100 Tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Free Thyroxine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Free Thyroxine Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
2×50 Tests/kit EUDAMED
3013782 EUDAMED
1×50 Tests/kit EUDAMED
3013781 EUDAMED
1×100 Tests/kit EUDAMED
3008734 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202223884 EUDAMED
06925794519689 EUDAMED
06925794511799 EUDAMED
Basic UDI-DI
B-06942202223884 EUDAMED
B-06925794519689 EUDAMED
B-06925794511799 EUDAMED
EMDN Code
W01020402 FREE THYROXINE EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Free Thyroxine Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED c6e1d384-2d9d-49f5-9eeb-b950eafab0cc 61 fields · synced Aug 3, 2026
  • EUDAMED 3143101b-3b01-4bc9-8496-45136ff580a7 61 fields · synced May 17, 2026
  • EUDAMED cfe0edb4-b425-46da-8dd2-8b0bd948d941 61 fields · synced May 17, 2026