Identity
- Trade Name
- Talk Pad 10- Gen 2 EUDAMED
- Device Name
- Talk Pad EUDAMED
- Model / Reference
- TP10E EUDAMEDTP10H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446901359 EUDAMED05060446901366 EUDAMED
- Basic UDI-DI
- 506044690TalkPadGA EUDAMED
- Direct Marketing DI
- 05060446901359 EUDAMED05060446901366 EUDAMED
- EMDN Code
- Y210915 VOCAL SYNTHESIS DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Talk Pad 10- Gen 2 by Smartbox Assistive Technology Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506044690TalkPadGA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smartbox Assistive Technology Limited
- EUDAMED SRN
- GB-MF-000008343
- Authorised Representative
- REHAVISTA GmbH DE-AR-000030297
Sources (2)
- EUDAMED abc4980e-11bf-4311-8d8f-a2a632f7b860 61 fields · synced Jul 27, 2026
- EUDAMED 9b8ba349-edb9-484d-9183-61e67b37a5ec 61 fields · synced May 18, 2026