Skip to content

biotical FOB Card ( +PC +NC)

by Biotical Health S.L.U Spain EUDAMED

Ref RTB25FCNModel biotical FOB Card ( +PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo FOB +1 C. Negativo universal) EMDN W0102160203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942141894 Basic UDI-DIDate25 Mar 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  • Withdrawn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

Device Name
biotical FOB Card
Model / Reference
biotical FOB Card ( +PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo FOB +1 C. Negativo universal), RTB25FCN
Primary DI / UDI-DI
84365942141894
Basic UDI-DI
B-84365942141894
EMDN Code
W0102160203 Fecal occult blood - 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 (1)

  • EUDAMED 61aca5e9-efea-4558-9a5e-019ab59544d8 61 fields · synced 22 Oct 2026