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NEONATAL 17-OHP Screening FLISA

by LaCAR MDx Technologies 2 variants

Ref I-MI-192Model I-MI

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430003908I-MI-H4 Basic UDI-DI 05430003908136UDI-DIDate11 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
I-MI, I-MI-192
Primary DI / UDI-DI
05430003908136
Basic UDI-DI
5430003908I-MI-H4
Direct Marketing DI
05430003908136
EMDN Code
W0102050107 17 oh progesterone
Device Class
Class C
EU 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

  • 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