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Withings SA

France · Issy-Les-Moulineaux

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 2Class II 11Class III 0

plus 14 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

IIa 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States14 registration records, 8 510(k), 0 PMA, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: Withings · WITHINGS

FDA 510(k) clearances by year

12011

12014

12016

12021

12023

12024

22025

FDA listed device types

showing 8 of 13

Analyzer, Body Composition, Exempt 1System, Measurement, Blood-Pressure, Non-Invasive 1Transmitters And Receivers, Electrocardiograph, Telephone 1Ventilatory Effort Recorder 1Clinical Electronic Thermometer 1Electrocardiograph Software For Over-The-Counter Use 1Device, Galvanic Skin Response Measurement 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252474	Withings BeamO (SCT02)	2025-11-10
US	K240795	Withings ECG App	2025-06-15
US	K231667	Withings Sleep Rx	2024-09-06
CA	98027	WITHINGS THERMO SMART TEMPORAL THERMOMETER	Class II
CA	99160	NOKIA THERMO SMART TEMPORAL THERMOMETER	Class II
CA	99432	NOKIA WIRELESS BLOOD PRESSURE MONITOR	Class II

Withings SA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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