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WITHINGS

EU DECLARATION OF CONFORMITY

Withings, under its sole responsibility, declares that the above-named products conform to the essential requirements of the following Directives:

Applied European Directives

Manufacturer

Withings
2 rue Maurice Hartmann
92130 Issy Les Moulineaux
France
SRN: FR-MF-000009505

Notified Body

Ente Certificazione Macchine
Via Ca Bella 243
40053 Valsamoggia, Castello di Serravalle
Italy
Notified body number: 1282

Swiss Authorized Representative

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

Medical Device Model WBS08 WBS12 WBS13
Trade Name Withings Body Scan Withings Body Comp Withings Body Smart
Catalog number WBS08-White-All-Inter
WBS08-Black-All-Inter		 WBS12-White-All-Inter
WBS12-Black-All-Inter		 WBS13-White-All-Inter
WBS13-Black-All-Inter
EMDN Code Z12062404 - ELECTRODERMIC SIGNAL BIOFEEDBACK SYSTEMS
Basic UDI DI 3700546707957WS
Risk Classification (according to 2017/745 annex VIII) Class IIa, rule 4 and 10

Intended purpose

Withings Smart Scales are intended to detect and follow-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 vascular age.

Supplied Accessories: Charging Cable

Compliance Details

Medical Device Regulation

Withings declares under its sole responsibility that the devices subject to this declaration are in conformity with the standards mentioned below and meet the requirements specified in Annex I:

Waste Electrical and Electronic Equipment Directive

The device subject to the directive 2012/19/EU is marked with the logo from Annex IX and Withings supplies recycling information.

Radio Equipment Directive

The conformity assessment procedure as detailed in Annex III has been followed and performed.

Health&Safety (Article 3.1(a))

EMC (Article 3.1(b))

RF Spectrum (Article 3.2)

RoHS Directive

The device complies with the below-mentioned standards and meets the requirements specified in Article 4 of the 2011/65/EU Directive amended by 2015/863/EU. List of RoHS restricted substances acceptation limits values tolerated and verification methods to ensure compliance:

Substances and Acceptance Limits Verification Methods
N/A IEC 62321-1:2013
IEC 62321-2:2013
IEC 62321-3:2013
Mercury (0,1%) EN 62321-4: 2013+A1:2017
Cadmium (0,01%)
Lead (0,1%)		 IEC 62321-5: 2013
PBBs (0,1%)
PBDEs (0,1%)		 EN 62321-6: 2015
Hexavalent chromium (0,1%) EN 62321-7-1: 2015
Phthalates (DEHP, BBP, DBP, DIBP) (0,1%) EN 62321-8:2017

Additional Compliance

Lithium-ion Battery: IEC 62133-2:2017/A1:2021 (EN 62133-2:2017/A1:2021) (only wbs08)

Thus, CE 1282 is placed on the product.

EC Certificate No: ECM22MDR001 – Expiry date: 22/12/2027

Signed on behalf of Withings, in Issy-les-Moulineaux,

Name: Xavier Debreuil
Function: Product Director

Signed by Xavier Debreuil

Xavier Debreuil

I approve this document
25-Jun-2025 | 17:37 CEST

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