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biotical C. difficile Toxins A + B Card (+PC +NC)

by Biotical Health S.L.U Spain EUDAMED

Ref RTB25CDCN, RTB25CDCModel biotical C. difficile Toxins A + B Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B +1 C. Negativo universal), biotical C. difficile Toxins A + B Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B) EMDN W0105090106

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942150940 Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
biotical C. difficile Toxins A + B Card (+PC +NC)
biotical C. difficile Toxins A + B Card (+PC)
Model / Reference
biotical C. difficile Toxins A + B Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B +1 C. Negativo universal), RTB25CDCN, biotical C. difficile Toxins A + B Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B), RTB25CDC
Primary DI / UDI-DI
84365942150940, 84365942150872
Basic UDI-DI
B-84365942150940, B-84365942150872
EMDN Code
W0105090106 Clost. diff. incl gdh and/or toxin a and b - rt & poc
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000018831

Other devices from Biotical Health S.L.U

See all devices from Biotical Health S.L.U →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 3b58ebee-2cf1-4ecb-91c0-a3a20de374ec 61 fields · synced 22 Oct 2026
  • EUDAMED 84365942150872|B-84365942150872 61 fields · synced 18 May 2026