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TruVue

by BioFynder Limited United Kingdom EUDAMED

Ref TV20006

EMDN W0102160703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-15065023763440 Basic UDI-DIDate7 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
hs-cTnI Test (FIA)
Model / Reference
TV20006
Primary DI / UDI-DI
15065023763440
Basic UDI-DI
B-15065023763440
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
Market of Registration
Italy

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 9ece9efd-a518-4f5a-80d8-11b337d5c6db 61 fields · synced 22 Oct 2026