EUDAMED device
Loss of Pulse Detection
EUDAMED device 00810073612334 · Fitbit LLC
Key facts
| Primary DI | 00810073612334 |
|---|---|
| Trade name | Loss of Pulse Detection |
| Device name | Loss of Pulse Detection |
| Reference or catalog number | FB612 |
| Model | FB612 |
| Manufacturer | Fitbit LLC |
| Manufacturer SRN | US-MF-000007439 |
| Risk class | Class IIa |
| EMDN code | Z12050392 |
| EMDN description | ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Sep 18, 2024 |
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: