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NEONATAL TSH Screening FLISA

by LaCAR MDx Technologies Belgium EUDAMED

Ref I-MH-192Model I-MH

EMDN W01020403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430003908I-MH-GZ Basic UDI-DIDate11 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

Model / Reference
I-MH, I-MH-192
Primary DI / UDI-DI
05430003908082
Basic UDI-DI
5430003908I-MH-GZ
Direct Marketing DI
05430003908082
EMDN Code
W01020403 Neonatal thyroid stimulating hormone
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 2d63d121-d34c-4dcd-b69d-309a1a1fe24c 61 fields · synced 24 Oct 2026