EUDAMED device
FitLife Mask, Extra Large, with Headgear, International
EUDAMED device 00606959026339 · Respironics Inc.
Key facts
| Primary DI | 00606959026339 |
|---|---|
| Trade name | FitLife Mask, Extra Large, with Headgear, International |
| Device name | FitLife Family |
| Reference or catalog number | 1089994 |
| 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 | Mar 10, 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: