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TruReno

by BioFynder Limited EUDAMED

Active European Union

Ref TR10006, TR10001, TR10003, TR10007, TR10005, TR10004Model TR100

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-15065026245011 Basic UDI-DIDate29 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Hemoglobin Test Strips
Handheld Electrochemical Meter
Blood Uric Acid Test Strips
Lipid Test Strips
Electrochemical control
Creatinine Strips
Model / Reference
TR10006, TR100, TR10001, TR10003, TR10007, TR10005, TR10004
Primary DI / UDI-DI
15065026245011, 15065023763884, 15065023763990, 15065026245028, 15065026245004, 15065023763952
Basic UDI-DI
B-15065026245011, 5065023763TR10001Y9, B-15065023763990, B-15065026245028, B-15065026245004, B-15065023763952
EMDN Code
W0101060107, W0201010105, W0101060106, W0101060109, W010106010801, W0101060112
Device Class
Class IVD General
Class A
Market of Registration
Finland
Poland
Cyprus

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

  • 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