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airLUX Max Headlight Package

by LumaDent Inc United States EUDAMED

Ref PRE-ALX-MXModel PRE-ALX

EMDN Z129004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08600007030ALX-HL-PKGZP Basic UDI-DIDate3 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
airLUX Headlight Package
Model / Reference
PRE-ALX, PRE-ALX-MX
Primary DI / UDI-DI
00860000703048
Basic UDI-DI
08600007030ALX-HL-PKGZP
Direct Marketing DI
00860000703048
EMDN Code
Z129004 Light sources
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000040330
Authorised representative
Brilitas Pharmaceuticals EU OÜ EE-AR-000032004

Other devices from LumaDent Inc

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c3d67497-1fce-4621-9156-7895f001f824 61 fields · synced 22 Oct 2026