Identity
- Trade Name
- Talk Pad 8 - Gen 2 EUDAMED
- Device Name
- Talk Pad EUDAMED
- Model / Reference
- TP08E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446901342 EUDAMED
- Basic UDI-DI
- 506044690TalkPadGA EUDAMED
- Direct Marketing DI
- 05060446901342 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 8 - 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 |
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Manufacturer
- Manufacturer
- Smartbox Assistive Technology Limited
- EUDAMED SRN
- GB-MF-000008343
- Authorised Representative
- REHAVISTA GmbH DE-AR-000030297
Sources (1)
- EUDAMED 31325729-aeec-4f4d-948f-69c1b8ecef20 61 fields · synced Jun 19, 2026