FDA Registration
Active
🇭🇰 Hong Kong
Withings HK Limited
Reg #: 3013689228
·
FEI: 3013689228
·
Expires 2026
Products
12
Proprietary Names
21
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Withings HK Limited
- Registration Number
- 3013689228
- FEI Number
- 3013689228
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit A, 25F, Billion Plaza II, 10 Cheung Yue Street, Cheung Sha Wan
- City
- Hong-Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K160544
Owner / Operator
- Firm Name
- Withings (France)
- Operator Number
- 10035674
- Address
- 2 rue Maurice Hartmann
- City
- Issy-les-Moulineaux
- State
- FR-NOTA
- Postal Code
- 92130
- Country
- FR
- Correspondent
- Xavier Debreuil
US Agent
- Business Name
- Emergo Global Consulting LLC
- Contact Name
- Greg Swanson
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2016-06-23 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-10-07 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-10-07 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2021-10-07 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2013-01-31 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-11-14 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2025-11-14 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-09-07 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2012-08-30 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2024-09-12 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2020-02-27 |
| Device, Galvanic Skin Response Measurement | GZO | Class 2 | Neurology | No | 2024-01-18 |
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
Withings Scan Monitor 2 (Body Scan, wbs08; BodyScan 2, WBS15)
WBS05
WBS08
WBS13
WBS12
WBS14
Establishment Types
Export Device to the United States But Perform No Other Operation on Device