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NEONATAL T-GAL Screening Fluo

by LaCAR MDx Technologies Belgium EUDAMED

Ref I-MB-576Model I-MB EMDN W01010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05430003908044 Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
I-MB-576, I-MB
Primary DI / UDI-DI
05430003908044
Basic UDI-DI
B-05430003908044, 5430002471I-MB-DM
Direct Marketing DI
05430003908044
EMDN Code
W01010199 Enzymes - other
Device Class
Class IVD General
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 (2)

  • EUDAMED df7d8db4-153e-477f-af25-e856a0bab524 61 fields · synced 24 Oct 2026
  • EUDAMED 05430003908044|5430002471I-MB-DM 61 fields · synced 13 Oct 2026