EUDAMED device
Fitbit ECG App
EUDAMED device 00810038851983 · Fitbit LLC
Key facts
| Primary DI | 00810038851983 |
|---|---|
| Trade name | Fitbit ECG App |
| Device name | Fitbit ECG App |
| Reference or catalog number | FB603 |
| Model | FB603 |
| Manufacturer | Fitbit LLC |
| Manufacturer SRN | US-MF-000007439 |
| Risk class | Class IIa |
| EMDN code | Z12050382 |
| EMDN description | ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 13, 2022 |
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: