EUDAMED device
Mark 5 Nuvo Lite
EUDAMED device 00038214001520 · Nidek Medical Products Inc.
Key facts
| Primary DI | 00038214001520 |
|---|---|
| Trade name | Mark 5 Nuvo Lite |
| Device name | Nidek Medical Oxygen Concentrators |
| Reference or catalog number | 925-OCSI |
| Manufacturer | Nidek Medical Products Inc. |
| Manufacturer SRN | US-MF-000007253 |
| Risk class | Class IIb |
| EMDN code | Z12159004 |
| EMDN description | OXYGEN CONCENTRATORS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Feb 26, 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: