Withings
FR-MF-000009505 · France · Issy-les-Moulineaux
Withings is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 34 |
|---|
Most frequent device types declared: HWA10, SCT02, wbsecg, SCT-CPN, HWA-CPN.
Among these devices, 34 are declared active, 28 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Withings (FR) · FDA 3008820594 |
| Devices in EUDAMED | 34 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ECM22MDR001 | supplemented | 2027-12-22 |