EUDAMED device
Large Amara Gel Mask with Reduced Size Frame and Headgear International
EUDAMED device 00606959021181 · Respironics Inc.
Key facts
| Primary DI | 00606959021181 |
|---|---|
| Trade name | Large Amara Gel Mask with Reduced Size Frame and Headgear International |
| Reference or catalog number | 1090426 |
| Model | Amara Gel SE |
| Manufacturer | Respironics Inc. |
| Manufacturer SRN | US-MF-000002301 |
| Risk class | Class IIa |
| EMDN code | R0301010202 |
| EMDN description | NIV MASKS |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jul 16, 2025 |
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: