EUDAMED device
Duet
EUDAMED device 00817020020075 · Intelligent Hearing Systems
Key facts
| Primary DI | 00817020020075 |
|---|---|
| Trade name | Duet |
| Device name | USB Jr Duet |
| Reference or catalog number | M010300 |
| Model | M010300 |
| Manufacturer | Intelligent Hearing Systems |
| Manufacturer SRN | US-MF-000011473 |
| Risk class | Class IIa |
| EMDN code | Z12140301,Z12149001 |
| EMDN description | EVOKED POTENTIAL AUDIOMETRY INTEGRATED SYSTEMS|OTOACOUSTIC EMISSIONS EQUIPMENT |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Mar 14, 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)