EUDAMED device
NovaChat 8.4 Keyguard 15 location
EUDAMED device 00816486021091 · PRENTKE ROMICH COMPANY
Key facts
| Primary DI | 00816486021091 |
|---|---|
| Trade name | NovaChat 8.4 Keyguard 15 location |
| Device name | NovaChat 5.4 |
| Reference or catalog number | 19254-15-A |
| Model | NC5.4 |
| Manufacturer | PRENTKE ROMICH COMPANY |
| Manufacturer SRN | US-MF-000018695 |
| Risk class | Class I |
| EMDN code | Y214212 |
| EMDN description | VOICE GENERATORS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Feb 23, 2023 |
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: