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biotical H. pylori Card

by Biotical Health S.L.U Spain EUDAMED

Ref RTB25PGModel biotical H. pylori Card / 25 test rápidos con viales para muestra fecal (sin controles externos). EMDN W0105090102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84365942149746 Basic UDI-DIDate22 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  • Withdrawn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 H. pylori Card / 25 test rápidos con viales para muestra fecal (sin controles externos)., RTB25PG
Primary DI / UDI-DI
84365942149746
Basic UDI-DI
B-84365942149746
EMDN Code
W0105090102 H. pylori - 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 ae2ce72f-0814-40e4-b6c1-2fb6c0a259dc 61 fields · synced 22 Oct 2026