Identity
- Trade Name
- GoTalk Fit EUDAMED
- Device Name
- GoTalk Product Line EUDAMED
- Model / Reference
- GoTalk EUDAMEDGTF-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860011726753 EUDAMED
- Basic UDI-DI
- 08600117268GTVJ EUDAMED
- Direct Marketing DI
- 00860011726753 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 Fit 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 9da7b503-34f2-4d14-8454-3787b21a8471 61 fields · synced Aug 3, 2026