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Mona Glc

by MONA.health Belgium EUDAMED

Ref MONA GLC

EMDN Z12129092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54199802811AIOphthaGLCJB Basic UDI-DIDate1 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
Mona Glc
Model / Reference
MONA GLC
Primary DI / UDI-DI
05419980281111
Basic UDI-DI
54199802811AIOphthaGLCJB
EMDN Code
Z12129092 Various ophtalmology instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000021612

Other devices from MONA.health

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 86adc7ad-8547-4c03-98c2-eacbca055566 61 fields · synced 22 Oct 2026