FDA Registration
Active
🇫🇷 France
Withings
Reg #: 3008820594
·
FEI: 3008820594
·
Expires 2026
Products
13
Proprietary Names
22
Establishment Types
4
Classifications
13
Registration Details
- Registration Name
- Withings
- Registration Number
- 3008820594
- FEI Number
- 3008820594
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 rue Maurice Hartmann
- City
- Issy-les-Moulineaux Ile-de-France
- Country
- FR
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 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2012-08-30 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-11-14 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2025-11-14 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2025-11-14 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2020-02-27 |
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2025-07-29 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-10-07 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2021-10-07 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-12-13 |
| Device, Galvanic Skin Response Measurement | GZO | Class 2 | Neurology | No | 2024-01-18 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2024-09-12 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2013-01-31 |
Proprietary Names
Withings Thermo
WBS06
WBS04
WBS09
Withings WS-30, WS-50
Withings BeamO, Model: SCT02, REF: SCT02-02
Withings BeamO Pro, Model: SCT02, REF: SCT02-03
WBS05
WBS08
WBS13
WBS12
WBS14
Withings ECG App
Scan Monitor (ScanWatch, HWA09)
Scan Monitor (ScanWatch 2, HWA10)
Withings BPM Vision, Model: WPM07, REF: WPM07-08
Withings BPM Pro 2, Model: WPM07, REF: WPM07-07
Withings Scan Monitor 2 (Body Scan, wbs08; BodyScan 2, WBS15)
WPM06- Withings BPM Connect Pro
WPM05- Withings BPM Connect
Withings Sleep Rx
Withings Smart Kid Scale WS-40
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device