Identity
- Trade Name
- GoTalk 20+ Lite Touch EUDAMED
- Device Name
- GoTalk Product Line EUDAMED
- Model / Reference
- GoTalk EUDAMEDGTL-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860011726708 EUDAMED
- Basic UDI-DI
- 08600117268GTVJ EUDAMED
- Direct Marketing DI
- 00860011726708 EUDAMED
- EMDN Code
- Y214212 VOICE GENERATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
GoTalk 20+ Lite Touch by Attainment Company, Inc. — 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 | 08600117268GTVJ | Class I | Active |
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Manufacturer
- Manufacturer
- Attainment Company, Inc.
- EUDAMED SRN
- US-MF-000043650
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 1f497e96-c959-48af-b4a6-85e2b4204731 61 fields · synced Jun 19, 2026