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SuperNova Magnifier and Speech

by Dolphin Computer Access Ltd United Kingdom EUDAMED

Ref PS4KModel SuperNova Magnifier & Speech v21

EMDN Y210606,Y210609,Y210915

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5065007755PS45H Basic UDI-DIDate28 Jun 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
SuperNova Magnifier & Speech
Model / Reference
SuperNova Magnifier & Speech v21, PS4K
Primary DI / UDI-DI
05065007755013
Basic UDI-DI
5065007755PS45H
EMDN Code
Y210606,Y210609,Y210915
Device Class
Class I
Special Device Type
Software
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000024252
Authorised representative
SENSUS Consulting Ltd IE-AR-000020337

Other devices from Dolphin Computer Access Ltd

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 8a0aea06-bf25-48d8-9e43-0872050a9027 61 fields · synced 22 Oct 2026