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Talk Pad 10- Gen 2

by Smartbox Assistive Technology Limited United Kingdom EUDAMED

Ref TP10H

EMDN Y210915

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506044690TalkPadGA Basic UDI-DIDate6 Feb 2026RegisteredStatusActive

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
Talk Pad
Model / Reference
TP10H
Primary DI / UDI-DI
05060446901366
Basic UDI-DI
506044690TalkPadGA
Direct Marketing DI
05060446901366
EMDN Code
Y210915 Vocal synthesis devices
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000008343
Authorised representative
REHAVISTA GmbH DE-AR-000030297

Other devices from Smartbox Assistive Technology Limited

See all devices from Smartbox Assistive Technology Limited →

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 9b8ba349-edb9-484d-9183-61e67b37a5ec 61 fields · synced 22 Oct 2026