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Baleno Editor

by Mesa Ideas SRL EUDAMED

Withdrawn No longer placed on the EU market

Ref MISWBA00Model Baleno

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957138MISWBA00E8 Basic UDI-DIDate26 Oct 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Software per la Comunicazione Aumentativa Alternativa
Model / Reference
Baleno, MISWBA00
Primary DI / UDI-DI
08059571380150
Basic UDI-DI
805957138MISWBA00E8
Direct Marketing DI
08059571380150
EMDN Code
Y214224 Augmentative software
Device Class
Class I
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029839

Other devices from Mesa Ideas SRL

See all devices from Mesa Ideas SRL →

Properties

Show properties
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