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Elita Femtosecond Laser System

by AMO Ireland EUDAMED

Withdrawn Not intended for the EU market

Ref 0155-1004

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5050474a000609J Basic UDI-DIDate28 Sep 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
0155-1004
Primary DI / UDI-DI
05050474824942
Basic UDI-DI
5050474a000609J
Direct Marketing DI
05050474824942
EMDN Code
Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
IE-MF-000013704

Other devices from AMO Ireland

See all devices from AMO Ireland →

Properties

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