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Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 100 Tests/Kit

by Wuhan Life Origin Biotech Joint Stock Co., Ltd.

Identity

Trade Name
Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Device Name
Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
100 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06974986813647 EUDAMED
Basic UDI-DI
B-06974986813647 EUDAMED
EMDN Code
W01020408 THYROGLOBULIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock 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

EUDAMED SRN
CN-MF-000027340
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 9fe6b15e-45b1-4fc6-9a21-7735a929a2e4 61 fields · synced Oct 7, 2026