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biotical E. Coli O157:H7 Card (+PC +NC)

by Biotical Health S.L.U Spain EUDAMED

Ref RTB25ECNModel biotical E. Coli O157:H7 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo E. Coli O157:H7 +1 C. Negativo universal) EMDN W0105090199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942147452 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  • Withdrawn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 (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo E. Coli O157:H7 +1 C. Negativo universal), RTB25ECN
Primary DI / UDI-DI
84365942147452
Basic UDI-DI
B-84365942147452
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
  • Sterile
  • Animal Tissues
  • Professional Testing
Other properties (7)
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 29877c9c-4f10-4f8b-9039-816bfb58aae1 61 fields · synced 22 Oct 2026