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Eyerising Myopia Management Device

by Eyerising International Pty Ltd Australia EUDAMED

Ref RS-200-1A EMDN Z12120119

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number93595650RS-200-1AUG Basic UDI-DIDate12 Jan 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Eyerising Myopia Management Device
Model / Reference
RS-200-1A
Primary DI / UDI-DI
09359565000002
Basic UDI-DI
93595650RS-200-1AUG
EMDN Code
Z12120119 Ophthalmological treatment units
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000029570
Authorised representative
Compliance Management Solutions Europe LTD BG-AR-000020809

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 d25876f8-75b7-4547-bd95-614813921ad7 61 fields · synced 22 Oct 2026