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Ilert

by Optolab 3DTechnologies Limited Ireland EUDAMED

Ref Ilert v10

EMDN Z1212012092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539155185BASEDB Basic UDI-DIDate19 Feb 2026RegisteredStatusActive

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
Ilert
Model / Reference
Ilert v10
Primary DI / UDI-DI
05391551850004
Basic UDI-DI
539155185BASEDB
Direct Marketing DI
05391551850004
EMDN Code
Z1212012092 Instruments for the assessment of visual functionality - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000051764

Other devices from Optolab 3DTechnologies Limited

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 c6cd9d5e-0412-4464-905f-c3ad9c89f523 61 fields · synced 22 Oct 2026