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TruCell

by BioFynder Limited EUDAMED

Active European Union

Ref TC10001, TC10003, TC10002Model TC100

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5065023763TC100R8 Basic UDI-DIDate24 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Hematology Analyzer
Lyse
Diluent
Model / Reference
TC100, TC10001, TC10003, TC10002
Primary DI / UDI-DI
15065023763846, 15065023763860, 15065023763853
Basic UDI-DI
5065023763TC100R8, 5065023763LyseAL, 5065023763DiluentFN
EMDN Code
W0202010101, W0599
Device Class
Class A
Market of Registration
France

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 NoEUDAMEDYesEUDAMED
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Surgical Instrument YesEUDAMEDNoEUDAMED

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No