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biotical FOB Card (+PC)

by Biotical Health S.L.U Spain EUDAMED

Ref RTB25FCModel biotical FOB Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo FOB)

EMDN W0102160203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942141726 Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
biotical FOB Card
Model / Reference
biotical FOB Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo FOB), RTB25FC
Primary DI / UDI-DI
84365942141726
Basic UDI-DI
B-84365942141726
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 058e6977-9302-4441-a4ac-b2c1bb5fcf82 61 fields · synced 24 Oct 2026