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NEONATAL SCID Screening qPCR FLEX

by LaCAR MDx Technologies EUDAMED

Active European Union

Ref ZT-SCID-QPCR-FLEX-480Model ZT-SCID-QPCR-FLEX

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430003908SCIDFlexRT Basic UDI-DIDate11 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Model / Reference
ZT-SCID-QPCR-FLEX, ZT-SCID-QPCR-FLEX-480
Primary DI / UDI-DI
05430003908259
Basic UDI-DI
5430003908SCIDFlexRT
Direct Marketing DI
05430003908259
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

  • 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