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Baleno Player

by Mesa Ideas SRL Italy EUDAMED

Ref MISWBA00-pModel Baleno

EMDN Y214224

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805957138MISWBA00E8 Basic UDI-DIDate26 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Software per la Comunicazione Aumentativa Alternativa
Model / Reference
Baleno, MISWBA00-p
Primary DI / UDI-DI
08059571380495
Basic UDI-DI
805957138MISWBA00E8
Direct Marketing DI
08059571380495
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 & 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 9ca9a886-5924-4410-a7b5-07e4c392c688 61 fields · synced 24 Oct 2026