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Carbohydrate Antigen 19-9（CA19-9）Detection Kit（Magnetic Solid Phase Chemilumine…

EUDAMED

Class IVD General (EU MDR)

Ref 50 Tests/kit（DR1015-1）Model 50 Tests/kit

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

Identity

Trade Name
Carbohydrate Antigen 19-9（CA19-9）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Carbohydrate Antigen 19-9（CA19-9）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
50 Tests/kit EUDAMED
50 Tests/kit（DR1015-1） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969980199 EUDAMED
Basic UDI-DI
B-06974969980199 EUDAMED
EMDN Code
W0102030103 CANCER ANTIGEN 19-9 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

Carbohydrate Antigen 19-9（CA19-9）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 (1)

  • EUDAMED 150b51e9-0fc4-4deb-afbc-89e04f4292a1 61 fields · synced Oct 6, 2026