Skip to content

Z12120192

by Ural Telekomüni̇kasyon San. Ti̇c. a.ş Türkiye EUDAMED

Ref EyeCheckup v1

EMDN Z12120192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86830797467NVFundus5H Basic UDI-DIDate31 May 2022RegisteredStatusActive

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
NV Fundus
Model / Reference
EyeCheckup v1
Primary DI / UDI-DI
08683079746752
Basic UDI-DI
86830797467NVFundus5H
Direct Marketing DI
08683079746752
EMDN Code
Z12120192 Ophtalmology assessments and diagnosis instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024209

Other devices from Ural Telekomüni̇kasyon San. Ti̇c. a.ş

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 c5282973-2925-492f-aa6f-608ef2eefce1 61 fields · synced 22 Oct 2026