EUDAMED device
System One, Heated Tube
EUDAMED device 00606959006652 · Respironics Inc.
Key facts
| Primary DI | 00606959006652 |
|---|---|
| Trade name | System One, Heated Tube |
| Reference or catalog number | SYS1HT15 |
| Model | System One Heated Humidifier |
| 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 | Jul 18, 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: