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Antibodies to Thyroid Peroxidase (Anti-TPO) Assay Kit (Chemiluminescent Immunoa…

EUDAMED

Class IVD General (EU MDR)

Ref 25 Tests/KitRef 100 Tests/KitRef 50 Tests/Kit

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

Identity

Trade Name
Antibodies to Thyroid Peroxidase (Anti-TPO) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Device Name
Antibodies to Thyroid Peroxidase (Anti-TPO) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
25 Tests/Kit EUDAMED
100 Tests/Kit EUDAMED
50 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06974986814521 EUDAMED
06974986814545 EUDAMED
06974986814538 EUDAMED
Basic UDI-DI
B-06974986814521 EUDAMED
B-06974986814545 EUDAMED
B-06974986814538 EUDAMED
EMDN Code
W0102100301 THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES 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

Antibodies to Thyroid Peroxidase (Anti-TPO) Assay Kit (Chemiluminescent Immunoa… by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
EUDAMED SRN
CN-MF-000027340
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 9e7fc2d3-1c9d-4205-bbd2-4628bc07cd74 61 fields · synced Oct 6, 2026
  • EUDAMED 067c3d89-3c9f-434a-9482-ebee7377b8fc 61 fields · synced May 18, 2026
  • EUDAMED 181b1b07-890f-4aab-aa19-ff216baef5c8 61 fields · synced May 19, 2026