EUDAMED device
Dorma 500 Auto, with Humidifier, INTL
EUDAMED device 00606959036956 · Respironics Inc.
Key facts
| Primary DI | 00606959036956 |
|---|---|
| Trade name | Dorma 500 Auto, with Humidifier, INTL |
| Device name | REMstar, REMstar SE, Dorma |
| Reference or catalog number | INV501H |
| Manufacturer | Respironics Inc. |
| Manufacturer SRN | US-MF-000002301 |
| Risk class | Class IIa |
| EMDN code | Z1203010502 |
| EMDN description | ADULT PULMONARY VENTILATORS |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | May 1, 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: