EUDAMED device
BiPAP Pro BiFlex System One 60 Series INT
EUDAMED device 00606959069343 · Respironics Inc.
Key facts
| Primary DI | 00606959069343 |
|---|---|
| Trade name | BiPAP Pro BiFlex System One 60 Series INT |
| Device name | REMstar System (60 Series) |
| Reference or catalog number | IN661S |
| Manufacturer | Respironics Inc. |
| Manufacturer SRN | US-MF-000002301 |
| Risk class | Class IIa |
| EMDN code | Z12030102 |
| EMDN description | CONTINUOUS POSITIVE PRESSURE EQUIPMENT |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | May 29, 2025 |
At a glance
- No 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: