Withings HK Limited

FDA Device Registration & Listing · Hong-Kong, HK · Registration 3013689228

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013689228
FEI Number
3013689228
Entity Name
Withings HK Limited
City/State/Country
Hong-Kong, HK
Establishment Address
Unit A, 25F, Billion Plaza II, 10 Cheung Yue Street, Cheung Sha Wan, Hong-Kong 00000, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Withings (France) (Owner Number: 10035674)
Owner / Operator Contact Address
2 rue Maurice Hartmann, Issy-les-Moulineaux, FR-NOTA 92130, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231667
PMA Number
N/A

All Registered Proprietary Names

Withings Thermo Scan Monitor (ScanWatch, HWA09) Scan Monitor (ScanWatch 2, HWA10) Withings Smart Kid Scale WS-40 Withings BeamO, Model: SCT02, REF: SCT02-02 Withings BeamO Pro, Model: SCT02, REF: SCT02-03 WPM05- Withings BPM Connect WPM06- Withings BPM Connect Pro Withings BPM Vision, Model: WPM07, REF: WPM07-08 Withings BPM Pro 2, Model: WPM07, REF: WPM07-07 WBS06 WBS04 WBS09 Withings WS-30, WS-50 Withings Sleep Rx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-06-23
DQA Oximeter Cardiovascular Class 2 870.2700 2021-10-07
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2021-10-07
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2021-10-07
FRW Scale, Patient General Hospital Class 1 880.2720 2013-01-31
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-11-14
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2025-11-14
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-11-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-09-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-12-13
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2012-08-30
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-06-10
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2024-09-12

Official Correspondent

Xavier Debreuil

US Agent Details

Greg Swanson Business: Emergo Global Consulting LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Withings (France)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008820594 Withings Issy-les-Moulineaux Ile-de-France, FR
3008496197 IMPETO MEDICAL Issy-les-Moulineaux Ile-de-France, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013689228. Last updated year: 2026. Please use registration number 3013689228 when referencing this establishment in official correspondence.
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