EU DECLARATION OF CONFORMITY
Manufacturer

Notified Body

Withings
2 rue Maurice Hartmann
92130 Issy Les MoulineauxFranceEnte Certificazione Macchine
Via Ca Bella 243
40053 Valsamoggia, Castello di Serravalle
Italy

SRN: FR-MF-000009505

Notified body number: 1282

Swiss Authorized Representative
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
CH RN: CHRN-AR-20000310

Medical Device
ModelsWithings Body Scan

Withings Body Comp

wbs08

wbs12

EMDN CodeZ12062404 - ELECTRODERMIC SIGNAL BIOFEEDBACK SYSTEMS

Basic UDI DI

3700546707957WSRisk Classification (accordingto 2017/745 annex VIII)
Intended purpose

Class IIa, rule 4 and 10Withings Smart Scales are intended to detect andfollow-up peripheral autonomic neuropathies in an adult
population by performing measurements on the feet, on
intact skin or in the presence of damaged skin, such as,
but not limited to, blisters, callosities or wounds.
Additionally, they provide the following features without
medical purposes: measure weight, calculate Body Mass
Index (BMI), measure body composition, measure pulse
rate, measure pulse wave velocity, and estimate vascularage.

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2017/745 (MDR)−

ISO 13485:2016 (EN ISO 13485:2016/AC:2008/A11:2021)−

ISO 14155:2020 (EN ISO 14155:2020)−

ISO 14971:2019 (EN ISO 14971:2019/A11:2021)−

ISO 10993-1:2018 (EN ISO 10993-1:2020)−

ISO 15223-1:2021 (EN ISO 15223-1:2021)−

IEC 60601-1:2005/A2:2020 (EN 60601-1:2006/A2:2021)−

IEC 60601-1-2:2014/A1:2020 (EN 60601-1-2:2015/A1:2021)−

IEC 60601-1-6:2010/A2:2020 (EN 60601-1-6:2010/A2:2021)−

IEC 60601-1-11:2015/A1:2020 (EN 60601-1-11:2015/A1:2021)−

IEC 62304:2006/A1:2015 (EN 62304:2006/A1:2015)−

IEC 62366-1:2015/A1:2020 (EN 62366-1:2015/A1:2020)− ISO 20417:2021 (EN ISO 20417:2021)− IEC 62133-2:2017/A1:2021 (EN 62133-2:2017/A1:2021) (onlywbs08)− IEC 60601-2-47:2012 (EN 60601-2-47:2015) (only wbs08)−

2014/53/EU (RED)2014/30/EU (EMC)

IEC 60529:1989/A1:1999/A2:2013− EN 300 328 V2.2.2− EN 301 489-1 V2.2.3− EN 301 489-17 V3.2.4− IEC 62311:2019 (EN IEC 62311:2020 / EN 50665:2017)2011/65/EU
amendedby
2015/863/EU (RoHS)− IEC 62321-5:2013 (EN 62321-5:2014)− IEC 62321-4:2013/A1:2017 (EN 62321-4:2014/A1:2017)− IEC 62321-7-1:2015 (EN 62321-7-1:2015)− IEC 62321-6:2015 (EN 62321-6:2015)− IEC 62321-8:2017 (EN 62321-8:2017)− IEC 63000:2016 (EN IEC 63000:2018)

1907/2006 (REACH)
2014/35/EU (LVD)−ISO 12472:2003 (EN 12472:2020)−

IEC 62368-1:2018/C1:2020 (EN IEC 62368-1:2020/A11:2020)

We hereby declare under our sole responsibility that :- wbs08, Withings Body Scan
- wbs12, Withings Body Comp
comply with the above-mentioned standards and meet the requirements specified in:- Annex I of the 2017/745 Medical Device Regulation,
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-Article 3 of the 2014/53/EU Directive (RED),
Annex I of the 2014/30/EU Directive (EMC),
Article 4 of the 2011/65/EU Directive amended by 2016/863/EU (RoHS).

The conformity assessment of the quality management system and the technicaldocumentation according to Annex IX, Chapters I and III of the 2017/745 medical device
regulation has been performed by the Notified Body mentioned above.
EC Certificate No: ECM22MDR001 – Expiry date : 22/12/2027
Thus,

1282 is placed on the product

Signed on behalf of Withings, in Issy-les-Moulineaux, 23/01/2023.

Name:Xavier Debreuil
Function: Product Director
Signature:

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