EUDAMED device
Dexcom ONE+ CGM System
EUDAMED device 00386270003768 · Dexcom
Key facts
| Primary DI | 00386270003768 |
|---|---|
| Trade name | Dexcom ONE+ CGM System |
| Device name | Dexcom ONE+ CGM System |
| Reference or catalog number | STE-D7-003 |
| Manufacturer | Dexcom |
| Manufacturer SRN | US-MF-000010694 |
| Risk class | Class IIb |
| EMDN code | Z1204011501 |
| EMDN description | NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Jun 3, 2024 |
At a glance
- No 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: