← Back to catalogue

Thyroglobulin Antibody（TGAb）Detection Kit（Magnetic Solid Phase Chemiluminescent…

EUDAMED

Class IVD General (EU MDR)

Ref 200 Tests/kit（DR1006-3）Model 200 Tests/kitRef 100 Tests/kit（DR1006-2）Model 100 Tests/kitRef 50 Tests/kit（DR1006-1）Model 50 Tests/kit

by Biobase Diagnostic Technology (Shandong) Co., Ltd.

Identity

Trade Name
Thyroglobulin Antibody（TGAb）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMED
Device Name
Thyroglobulin Antibody（TGAb）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMED
Model / Reference
200 Tests/kit EUDAMED
200 Tests/kit（DR1006-3） EUDAMED
100 Tests/kit EUDAMED
100 Tests/kit（DR1006-2） EUDAMED
50 Tests/kit EUDAMED
50 Tests/kit（DR1006-1） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982131 EUDAMED
06974969981561 EUDAMED
06974969980991 EUDAMED
Basic UDI-DI
B-06974969982131 EUDAMED
B-06974969981561 EUDAMED
B-06974969980991 EUDAMED
EMDN Code
W0102100303 THYROGLOBULIN AUTOANTIBODY EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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 Antibody（TGAb）Detection Kit（Magnetic Solid Phase Chemiluminescent… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biobase Diagnostic Technology (Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025964
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (3)

  • EUDAMED 5c2cfe3a-6d5e-4b67-b692-728140fd48a4 61 fields · synced Oct 6, 2026
  • EUDAMED 50b8f4bc-c098-4d7b-aa30-f6bd273aabf4 61 fields · synced May 18, 2026
  • EUDAMED b3a465f1-ff50-4dd4-8c33-7ede8f4ca51b 61 fields · synced May 18, 2026