CE Medical (Europe regions)

Within the European Union, the Withings ScanWatch 2, and its software accessory, the Withings ScanWatch 2 companion app are CE marked according to the Medical Device Regulation (MDR) 2017/745.

The European Notified Body responsible for the assessment of this product is Ente Certificazione Macchine, an Italian Notified body with the following identification number 1282.
The reference of the CE certificate is ECM22MDR001.

The related manufacturer declaration of conformity for ScanWatch 2 is here.

The related manufacturer declaration of conformity for ScanWatch 2 Companion App is here.

Australia & New Zealand

The Withings ScanWatch 2 is registered within Australia and New-Zealand as a medical device.

Within Australia, the ARTG listing number is 493929

Within New-Zealand, the WAND reference is 250523-WAND-75LON3

United States

For the US, the Withings ECG App is cleared under the 510(k) Number K240795