EUDAMED device
CGM Informed Therapy Adjustment
EUDAMED device 00386270005342 · Dexcom
Key facts
| Primary DI | 00386270005342 |
|---|---|
| Device name | CGM Informed Therapy Adjustment |
| Reference or catalog number | SW14553 |
| Manufacturer | Dexcom |
| Manufacturer SRN | US-MF-000010694 |
| Risk class | Class IIb |
| EMDN code | Z12040292 |
| EMDN description | GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 19, 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: