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RapidFor™ C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Kit

EUDAMED

Class IVD General (EU MDR)

Ref VMD96

by Vitrosens Biotechnology Inc.

Identity

Trade Name
RapidFor™ C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Kit EUDAMED
Device Name
C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Kit EUDAMED
Model / Reference
VMD96 EUDAMED

Identifiers

Primary DI / UDI-DI
08683548254993 EUDAMED
Basic UDI-DI
B-08683548254993 EUDAMED
EMDN Code
W0105011803 C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION 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

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMED

Surgical Instrument

No

EUDAMED

RapidFor™ C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Kit by Vitrosens Biotechnology Inc. — 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

Manufacturer
Vitrosens Biotechnology Inc.
EUDAMED SRN
TR-MF-000026452

Sources (1)

  • EUDAMED c56cf6d1-1da1-452c-8f1f-d3ef4c9a8baf 61 fields · synced Jun 17, 2026