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biotical Yersinia enterocolitica O:9 Card

by Biotical Health S.L.U

Ref RTB25Y9, RTB25Y9CN, RTB25Y9CModel biotical Yersinia enterocolitica O:9 Card / 25 test rápidos con viales para muestra fecal (sin controles externos)., biotical Yersinia enterocolitica O:9 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9 +1 C. Negativo universal), biotical Yersinia enterocolitica O:9 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9)

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942151480 Basic UDI-DI Date27 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Trade Name
biotical Yersinia enterocolitica O:9 Card
biotical Yersinia enterocolitica O:9 Card (+PC +NC)
biotical Yersinia enterocolitica O:9 Card (+PC)
Model / Reference
biotical Yersinia enterocolitica O:9 Card / 25 test rápidos con viales para muestra fecal (sin controles externos)., RTB25Y9, biotical Yersinia enterocolitica O:9 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9 +1 C. Negativo universal), RTB25Y9CN, biotical Yersinia enterocolitica O:9 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9), RTB25Y9C
Primary DI / UDI-DI
84365942151480, 84365942151626, 84365942151558
Basic UDI-DI
B-84365942151480, B-84365942151626, B-84365942151558
EMDN Code
W0105090199 Bacteriology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000018831

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Properties

  • 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