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Targeted qPCR SMA FLEX

by LaCAR MDx Technologies Belgium EUDAMED

Ref K-MF-480Model K-MF EMDN W0106010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430002471K-MF-EP Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
K-MF, K-MF-480
Primary DI / UDI-DI
05430002471754
Basic UDI-DI
5430002471K-MF-EP
Direct Marketing DI
05430002471754
EMDN Code
W0106010199 Monogenetic disorders tests - 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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: 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 4ac025eb-6010-4a80-98e8-54ae23e4adfd 61 fields · synced 23 Oct 2026