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TruVue

by BioFynder Limited United Kingdom EUDAMED

Ref TV10013

EMDN W0105010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-15065023763129 Basic UDI-DIDate27 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
H. Pylori Ab Rapid Test (LFA)
Model / Reference
TV10013
Primary DI / UDI-DI
15065023763129
Basic UDI-DI
B-15065023763129
EMDN Code
W0105010402 H. pylori antibody assays
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
UK-MF-000047512
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from BioFynder Limited

See all devices from BioFynder Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b0bfcf8f-497d-44b1-b47e-28d57318c2e0 61 fields · synced 24 Oct 2026