EUDAMED device
iTalk4
EUDAMED device 00186648000531 · AbleNet Inc.
Key facts
| Primary DI | 00186648000531 |
|---|---|
| Trade name | iTalk4 |
| Device name | iTalk4 |
| Reference or catalog number | 10000028 |
| Model | 10000028 |
| Manufacturer | AbleNet Inc. |
| Manufacturer SRN | US-MF-000008722 |
| Risk class | Class I |
| EMDN code | Y214212 |
| EMDN description | GÉNÉRATEURS DE VOIX|GENERATORI DI VOCE|VOICE GENERATORS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 21, 2021 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: