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BrainEye app

by Neuro Optica Operations Pty Ltd t/a BrainEye Australia EUDAMED

Ref BrainEye app

EMDN Z12120111

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number93090019171-BrainEyeApp9W Basic UDI-DIDate3 Mar 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

Model / Reference
BrainEye app
Primary DI / UDI-DI
09309001917005
Basic UDI-DI
93090019171-BrainEyeApp9W
Direct Marketing DI
09309001917005
EMDN Code
Z12120111 Eye movement monitors
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
AU-MF-000045833
Authorised representative
MDSS GmbH DE-AR-000005430

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 3c210d60-6a65-494d-9d22-d78f8b7b77aa 61 fields · synced 22 Oct 2026