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Data / Medical devices / Hong Kong / Withings HK Limited

Withings HK Limited: FDA-registered device maker in Hong-Kong, Hong Kong, 8 510(k) clearances

Withings HK Limited is registered with the FDA (registration 3013689228) in Hong-Kong, Hong Kong. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 10, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Withings HK Limited
FDA registration number
3013689228
Address
Unit A, 25F, Billion Plaza II 10 Cheung Yue Street, Cheung Sha Wan, Hong-Kong, Hong Kong, 00000
Owner or operator
Withings (France) (10035674)
Roles
Exporter to the US
First device listed
August 30, 2012
Registered through
2026
Brand names listed
Scan Monitor (ScanWatch 2, HWA10), Scan Monitor (ScanWatch, HWA09), WBS04, WBS05, WBS06, WBS08, WBS09, WBS12 and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Body Composition, ExemptPUH2Exporter to the USaccessdata.fda.gov
Clinical Electronic ThermometerSDV2Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Device, Galvanic Skin Response MeasurementGZO2Exporter to the USaccessdata.fda.gov
ElectrocardiographDPS2Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Scale, PatientFRW1Exporter to the USaccessdata.fda.gov
Scale, Stand-On, PatientFRI1Exporter to the USaccessdata.fda.gov
Stethoscope, ElectronicDQD2Exporter to the USaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the USaccessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, TelephoneDXH2Exporter to the USaccessdata.fda.gov
Ventilatory Effort RecorderMNR2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 10, 2025K252474Withings BeamO (SCT02)DPSSubstantially EquivalentWithingsaccessdata.fda.gov
September 6, 2024K231667Withings Sleep RxMNRSubstantially EquivalentWithingsaccessdata.fda.gov
April 29, 2024K240102Blood Pressure Monitor (TMB-2287-B)DXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov
August 23, 2023K230812Withings Scan Monitor 2.0DPSSubstantially EquivalentWithingsaccessdata.fda.gov
June 30, 2023K223374Blood Pressure MonitorDXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov
October 5, 2021K201456Scan MonitorDPSSubstantially EquivalentWithings SAaccessdata.fda.gov
June 17, 2016K160544Withings Thermo (Model SCT01)FLLSubstantially EquivalentWithingsaccessdata.fda.gov
June 19, 2013K131395TRANSTEK BLOOD PRESSURE MONITORDXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.