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ITOS standalone

by Voigtmann GmbH Germany EUDAMED

Ref ITOS standalone

EMDN Z12120192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-ITOS-standaloneXB Basic UDI-DIDate19 Dec 2022RegisteredStatusWithdrawn

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
ITOS standalone
Model / Reference
ITOS standalone
Primary DI / UDI-DI
D-ITOS-standaloneXB
Basic UDI-DI
B-ITOS-standaloneXB
EMDN Code
Z12120192 Ophtalmology assessments and diagnosis instruments - medical device software
Device Class
Class IIa
Special Device Type
-1192
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000013049

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 82dfce86-911e-4c9a-9275-c0cf3e7647aa 61 fields · synced 24 Oct 2026