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LIODetect® TB-ST

by Lionex GmbH Germany EUDAMED

Ref 3010_EN EMDN W0105090199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-111418458750 Basic UDI-DIDate16 Sep 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
LIODetect® TB-ST Tuberculosis Rapid Test
Model / Reference
3010_EN
Primary DI / UDI-DI
111418458750
Basic UDI-DI
B-111418458750
EMDN Code
W0105090199 Bacteriology - rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000038504

Other devices from Lionex GmbH

Properties & raw data

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

Sources (1)

  • EUDAMED f2cd2965-6b9e-4fb5-9f2e-83bfe9a344cf 61 fields · synced 22 Oct 2026