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OdySight

by Tilak Healthcare SAS France EUDAMED

Ref OdySight

EMDN Z1212012092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03760377340013 Basic UDI-DIDate11 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
OdySight
Primary DI / UDI-DI
03760377340013
Basic UDI-DI
B-03760377340013
EMDN Code
Z1212012092 Instruments for the assessment of visual functionality - medical device software
Device Class
Class I
Special Device Type
-1192
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011759

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 4dff7a78-dd48-478a-9ff2-1fb239ff6913 61 fields · synced 22 Oct 2026