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TruUri

by BioFynder Limited United Kingdom EUDAMED

Ref TU10002, TU10001Model TU100

EMDN W0101060204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-15065026245264 Basic UDI-DIDate29 Dec 2025RegisteredStatusActive
European UnionCE/IVDD NumberB-15065026245264 Basic UDI-DIDate29 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Urine Test Strips
Urine Analyzer
Model / Reference
TU10002, TU100, TU10001
Primary DI / UDI-DI
15065026245264, 15065023763921
Basic UDI-DI
B-15065026245264, 5065023763TU10001ZG
EMDN Code
W0101060204, W020101020101
Device Class
Class IVD General
Class A
Market of Registration
Germany
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 YesEUDAMEDNoEUDAMED
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Surgical Instrument NoEUDAMEDYesEUDAMED
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED 46beb5bb-f1ce-463d-9056-01bddfae2826 61 fields · synced 22 Oct 2026
  • EUDAMED f85fef38-5ff8-4e32-afe2-1f61858da8a5 61 fields · synced 19 May 2026