EUDAMED device
Adult Mask / Large
EUDAMED device 00383730001203 · Respironics Inc.
Key facts
| Primary DI | 00383730001203 |
|---|---|
| Trade name | Adult Mask / Large |
| Device name | Silicone Face Mask |
| Reference or catalog number | HS81311-010 |
| Manufacturer | Respironics Inc. |
| Manufacturer SRN | US-MF-000002301 |
| Risk class | Class I |
| EMDN code | R030199 |
| EMDN description | RESPIRATORY MASKS - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jul 22, 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: