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biotical E. Coli O157:H7 Card

by Biotical Health S.L.U Spain EUDAMED

Ref RTB25EModel biotical E. Coli O157:H7 Card / 25 test rápidos con viales para muestra fecal (sin controles externos). EMDN W0105090199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942147216 Basic UDI-DIDate20 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  • Withdrawn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

Model / Reference
biotical E. Coli O157:H7 Card / 25 test rápidos con viales para muestra fecal (sin controles externos)., RTB25E
Primary DI / UDI-DI
84365942147216
Basic UDI-DI
B-84365942147216
EMDN Code
W0105090199 Bacteriology - rt & poc - other
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 ebe9fdf8-1cb5-4f3e-b5b5-9d0642ec76a3 61 fields · synced 22 Oct 2026