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Thyroid-stimulating Hormone（TSH） Detection Kit（Magnetic Solid Phase Chemilumine…

EUDAMED

Class IVD General (EU MDR)

Ref 200 Tests/kit（DR1001-3）Model 200 Tests/kitRef 50 Tests/kit（DR1001-1）Model 50 Tests/kit

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

Identity

Trade Name
Thyroid-stimulating Hormone（TSH） Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Thyroid-stimulating Hormone（TSH） Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
200 Tests/kit EUDAMED
200 Tests/kit（DR1001-3） EUDAMED
50 Tests/kit EUDAMED
50 Tests/kit（DR1001-1） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982087 EUDAMED
06974969980946 EUDAMED
Basic UDI-DI
B-06974969982087 EUDAMED
B-06974969980946 EUDAMED
EMDN Code
W01020410 THYROID STIMULATING HORMONE 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

Thyroid-stimulating Hormone（TSH） Detection Kit（Magnetic Solid Phase Chemilumine… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

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

Sources (2)

  • EUDAMED 42fb2fa0-195f-457d-ab8d-f5644fc88646 61 fields · synced Jul 22, 2026
  • EUDAMED 54bbc7a3-9fc7-4e2d-92da-54946c22d218 61 fields · synced May 18, 2026