EUDAMED device
Series Oro-Nasal Mask
EUDAMED device 00817136027319 · Hans Rudolph Inc
Key facts
| Primary DI | 00817136027319 |
|---|---|
| Device name | Series Oro-Nasal Mask |
| Reference or catalog number | 612796 |
| Model | 6500; 6600; 6700 - Series Oro-Nasal Mask |
| Manufacturer | Hans Rudolph Inc |
| Manufacturer SRN | US-MF-000004498 |
| Risk class | Class IIa |
| EMDN code | R0301010202 |
| EMDN description | NIV MASKS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 11, 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: