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Helicobacter Pylori Ab Rapid Test Cassette (Serum/Plasma)

by VitroBioChem SRL

Ref VT-HPBSP-25Model HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5944759080VTHPB25SPROB6HC Basic UDI-DI 05944759080010UDI-DIDate25 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA), VT-HPBSP-25
Primary DI / UDI-DI
05944759080010
Basic UDI-DI
5944759080VTHPB25SPROB6HC
Direct Marketing DI
05944759080010
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class B
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000010877

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Properties

  • Microbial Substances
  • Professional Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No