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Cortisol Fast Test Kit (Immunofluorescence Assay）

EUDAMED

Class IVD General (EU MDR)

Ref /Ref IF5110

by Getein Biotech, Inc.

Identity

Trade Name
Cortisol Fast Test Kit (Immunofluorescence Assay） EUDAMED
Cortisol Fast Test Kit (Immunofluorescence Assay) EUDAMED
Device Name
Cortisol Fast Test Kit (Immunofluorescence Assay） EUDAMED
Cortisol Fast Test Kit (Immunofluorescence Assay) EUDAMED
Model / Reference
/ EUDAMED
IF5110 EUDAMED

Identifiers

Primary DI / UDI-DI
06954414792034 EUDAMED
06954414733341 EUDAMED
Basic UDI-DI
B-06954414792034 EUDAMED
695441479203JT EUDAMED
EMDN Code
W0102060203 CORTISOL EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class B EUDAMED
Market of Registration
Romania EUDAMED
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

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

New Device

No

EUDAMED

Cortisol Fast Test Kit (Immunofluorescence Assay） by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Getein Biotech, Inc.
EUDAMED SRN
CN-MF-000017986
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED d17ddb0c-bbda-418b-aa2f-75838258446a 61 fields · synced Jul 10, 2026
  • EUDAMED 92d4af23-ab14-4909-a9e9-8b987ce009a2 61 fields · synced Jul 10, 2026