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ProLUX Headlight Package: Best Value

by LumaDent Inc United States EUDAMED

Ref PRE-PLX-BV

EMDN Z129004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08600007030PLX-HL-PKGFD Basic UDI-DIDate12 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

Model / Reference
PRE-PLX-BV
Primary DI / UDI-DI
00860000703000
Basic UDI-DI
08600007030PLX-HL-PKGFD
Direct Marketing DI
00860000703000
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 bc3193be-0ddc-488e-b1ed-7f1927f34e74 61 fields · synced 22 Oct 2026