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NEONATAL GAL-T Screening Fluo

by LaCAR MDx Technologies Belgium EUDAMED

Ref I-LU-576Model I-LU

EMDN W01010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430003908I-LU-J3 Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
NEONATAL GAL-T Screening Fluo
Model / Reference
I-LU, I-LU-576
Primary DI / UDI-DI
05430003908235
Basic UDI-DI
5430003908I-LU-J3
Direct Marketing DI
05430003908235
EMDN Code
W01010199 Enzymes - other
Device Class
Class C
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001212

Other devices from Lacar MDX Technologies

See all devices from Lacar MDX Technologies →

Properties & raw data

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

Sources (1)

  • EUDAMED 5b376619-8907-4667-8d5d-96d662ff35e5 61 fields · synced 24 Oct 2026