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biotical Rotavirus Card (+PC +NC)

by Biotical Health S.L.U

Ref RTB25RCNModel biotical Rotavirus Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Rotavirus +1 C. Negativo universal)

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-84365942144482 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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

Device Name
biotical Rotavirus Card
Model / Reference
biotical Rotavirus Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Rotavirus +1 C. Negativo universal), RTB25RCN
Primary DI / UDI-DI
84365942144482
Basic UDI-DI
B-84365942144482
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
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