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Cortisol Rapid Test Kit (Fluorescence Immunochromatographic Assay)

EUDAMED

Class IVD General (EU MDR)

Ref 5474C4X024

by Guangzhou Decheng Biotechnology Co., Ltd.

Identity

Trade Name
Cortisol Rapid Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
Device Name
Cortisol Rapid Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
Model / Reference
5474C4X024 EUDAMED

Identifiers

Primary DI / UDI-DI
06974464591593 EUDAMED
Basic UDI-DI
B-06974464591593 EUDAMED
EMDN Code
W0102060203 CORTISOL EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

Cortisol Rapid Test Kit (Fluorescence Immunochromatographic Assay) by Guangzhou Decheng Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000013536
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED d6ca0c17-0430-473a-9787-44fd04521a5b 61 fields · synced Jun 19, 2026