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TruAna

by BioFynder Limited United Kingdom EUDAMED

Ref TA10002

EMDN W01010404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-15065026245134 Basic UDI-DIDate29 Dec 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 22 Oct 2026

Device Name
General Chemistry I Test Panel
Model / Reference
TA10002
Primary DI / UDI-DI
15065026245134
Basic UDI-DI
B-15065026245134
EMDN Code
W01010404 Multiple parameters (mix of all) - clin. chem lab r.
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

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

Properties & raw data

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

Sources (1)

  • EUDAMED 473c3f1b-2270-48ab-ab59-7de52d6c5e72 61 fields · synced 22 Oct 2026