EUDAMED device
Dexcom ONE Continuous Glucose Monitoring System
EUDAMED device 00386270002297 · Dexcom
Key facts
| Primary DI | 00386270002297 |
|---|---|
| Trade name | Dexcom ONE Continuous Glucose Monitoring System |
| Device name | Dexcom ONE Continuous Glucose Monitoring System |
| Reference or catalog number | STP-DO-005 |
| Model | STP-DO-005/ Dexcom ONE Starter Kit - Spain mg/dL |
| Manufacturer | Dexcom |
| Manufacturer SRN | US-MF-000010694 |
| Risk class | Class IIb |
| EMDN code | Z1204011585 |
| EMDN description | INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE-USE SENSORS |
| Legislation | mdd |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Apr 25, 2023 |
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)