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VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag

by Operon, S.A.

Ref 9.23.1025.62.026 -Model 9.231.XXX.YY.ZZZ

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84295779231XW Basic UDI-DI 08429577007823UDI-DIDate1 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
SIMPLE H.pyl-Tf
Model / Reference
9.231.XXX.YY.ZZZ, 9.23.1025.62.026 -
Primary DI / UDI-DI
08429577007823
Basic UDI-DI
84295779231XW
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class B
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

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Properties

  • 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