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Simple H.pyl-Tf

by Operon, S.A. Spain EUDAMED

Ref 9.231.020.21.000, 9.231.020.16.000, 9.231.020.71.000Model 9.231.XXX.YY.ZZZ EMDN W0105090102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84295779231XW Basic UDI-DIDate1 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
9.231.XXX.YY.ZZZ, 9.231.020.21.000, 9.231.020.16.000, 9.231.020.71.000
Primary DI / UDI-DI
08429577004679, 08429577007861, 08429577004846
Basic UDI-DI
84295779231XW
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

Other devices from Operon, S.A.

See all devices from Operon, S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (3)

  • EUDAMED c542a370-bb8d-40f6-8f7b-13fb86624521 61 fields · synced 22 Oct 2026
  • EUDAMED 08429577007861|84295779231XW 61 fields · synced 18 May 2026
  • EUDAMED 08429577004846|84295779231XW 61 fields · synced 18 May 2026