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RapidFor™ Digoxin Rapid Test Kit (FIA)

EUDAMED

Class IVD General (EU MDR)

Ref VMPO20Ref VMPO19Model VMPO19EP

by Vitrosens Biotechnology Inc.

Identity

Trade Name
RapidFor™ Digoxin Rapid Test Kit (FIA) EUDAMED
RapidFor™ EUDAMED
Device Name
Digoxin Rapid Test Kit (FIA) EUDAMED
Cystatin C (FIA) EUDAMED
Model / Reference
VMPO20 EUDAMED
VMPO19EP EUDAMED
VMPO19 EUDAMED

Identifiers

Primary DI / UDI-DI
08683548250315 EUDAMED
Basic UDI-DI
B-08683548250315 EUDAMED
EMDN Code
W0102080101 DIGOXIN EUDAMED
W0102019008 CYSTATIN C EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED
Türkiye 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

Yes

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMEDEUDAMED

Surgical Instrument

No

EUDAMED

RapidFor™ Digoxin Rapid Test Kit (FIA) by Vitrosens Biotechnology Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
TR-MF-000026452

Sources (2)

  • EUDAMED 72b01f84-7911-4033-a1d7-fe43b8cb24f1 61 fields · synced Oct 8, 2026
  • EUDAMED 3f7796e7-4f69-430b-aa52-a71335915b7f 61 fields · synced Oct 8, 2026