Skip to content

TruLyta

by BioFynder Limited United Kingdom EUDAMED

Ref TL10002, TL10003

EMDN W01010403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-15065023763969 Basic UDI-DIDate26 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
Electrolyte Test Cartridge
Electrolyte control
Model / Reference
TL10002, TL10003
Primary DI / UDI-DI
15065023763969, 15065023763976
Basic UDI-DI
B-15065023763969, B-15065023763976
EMDN Code
W01010403, W0101050204
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
  • 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 (2)

  • EUDAMED d6d0b08f-a9fb-420f-9075-c8322a2b6392 61 fields · synced 22 Oct 2026
  • EUDAMED 15065023763976|B-15065023763976 61 fields · synced 18 May 2026