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: HWA-CPN, HWA10, SCT-CPN, SCT02, WPM04.
Among these devices, 34 are declared active, 28 with a measuring function.
Devices declared under this manufacturer
- BPM Core
- Withings BPM Connect
- Withings BeamO companion app
- Withings Body Comp
- Withings Body Scan
- Withings Body Smart
- Withings ECG App Display
- Withings ECG Device Display
- Withings ECG Monitor
- Withings ECG Monitor 2
- Withings Hypertension Notification
- Withings ScanWatch 2
Showing 12 of 34 declared devices.
Catalogue references include ECG-APP-DSP, ECG-DVC-DSP, ECG-SW2, ECGSW2, WBS12-White-All-Inter, hwa10-38-white-rosegold.
European nomenclature codes declared: Z12040199, Z12062404, Z12050392, Z12050382, Z1203020299, Z1203020501.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Withings (FR) · FDA 3008820594 |
| Devices in EUDAMED | 34 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 34 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 23.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | WITHINGS |
North American profile: Both markets. Withings is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ECM22MDR001 | supplemented | 2027-12-22 |