EUDAMED device
MADSEN Capella2
EUDAMED device 00817020029924 · Intelligent Hearing Systems
Key facts
| Primary DI | 00817020029924 |
|---|---|
| Trade name | MADSEN Capella2 |
| Device name | MADSEN Capella2 |
| Reference or catalog number | 8-04-15320 |
| Model | M011130 |
| Manufacturer | Intelligent Hearing Systems |
| Manufacturer SRN | US-MF-000011473 |
| Risk class | Class IIa |
| EMDN code | Z12149001 |
| EMDN description | OTOACOUSTIC EMISSIONS EQUIPMENT |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 16, 2022 |
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: