← Back to catalogue

Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassa…

EUDAMED

Class IVD General (EU MDR)

Ref 50 Tests/kit（DR1122-1）Model 50 Tests/kitRef 100 Tests/kit（DR1122-2）Model 100 Tests/kit

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

Identity

Trade Name
Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
50 Tests/kit EUDAMED
50 Tests/kit（DR1122-1） EUDAMED
100 Tests/kit EUDAMED
100 Tests/kit（DR1122-2） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969981486 EUDAMED
06974969982056 EUDAMED
Basic UDI-DI
B-06974969981486 EUDAMED
B-06974969982056 EUDAMED
EMDN Code
W0102050203 UNCONJUGATED (FREE) ESTRIOL 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

Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassa… 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 (2)

  • EUDAMED 7a8a6c9c-8da0-4ee8-bce0-542ae95035ee 61 fields · synced Oct 6, 2026
  • EUDAMED 964ec7b0-dc09-4951-a131-51e2f24cb182 61 fields · synced May 18, 2026