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Adrenocorticotropic Hormone（ACTH）Detection Kit（Magnetic Solid Phase Chemilumine…

EUDAMED

Class IVD General (EU MDR)

Ref 200 Tests/kit（DR1080-3）Model 200 Tests/kitRef 50 Tests/kit（DR1080-1）Model 50 Tests/kit

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

Identity

Trade Name
Adrenocorticotropic Hormone（ACTH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Adrenocorticotropic Hormone（ACTH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
200 Tests/kit EUDAMED
200 Tests/kit（DR1080-3） EUDAMED
50 Tests/kit EUDAMED
50 Tests/kit（DR1080-1） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982346 EUDAMED
06974969981202 EUDAMED
Basic UDI-DI
B-06974969982346 EUDAMED
B-06974969981202 EUDAMED
EMDN Code
W0102060401 ADRENOCORTICOTROPIC 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

Adrenocorticotropic Hormone（ACTH）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 c407a483-123e-4c04-9b82-c97eb2f58cb5 61 fields · synced Jul 22, 2026
  • EUDAMED 4e7de29c-7e08-4ff6-90e3-d0bd568dc225 61 fields · synced May 18, 2026