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LIODetect® Troponin I Rapid Test

by Lionex GmbH

Ref Troponin I_10_EN

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-11176130722523 Basic UDI-DI D-11176130722523UDI-DIDate28 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
LIODetect® Troponin I Rapid Test
Model / Reference
Troponin I_10_EN
Primary DI / UDI-DI
D-11176130722523
Basic UDI-DI
B-11176130722523
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
DE-MF-000038504

From the manufacturer

Manufacturer's product page: LIODetect®

Other devices from Lionex GmbH

Properties

  • Microbial Substances
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No