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PreMO

by Wolffsohn Research Ltd XI EUDAMED

Ref PreMO V1.3.6

EMDN Z12129092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50700028621PreMOV.1.3.63F Basic UDI-DIDate21 Dec 2023RegisteredStatusActive

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
PreMO
Model / Reference
PreMO V1.3.6
Primary DI / UDI-DI
05070002862109
Basic UDI-DI
50700028621PreMOV.1.3.63F
EMDN Code
Z12129092 Various ophtalmology instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000039220

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 0683593d-54be-461b-8e32-592a0c9ca49f 61 fields · synced 22 Oct 2026