FDA Registration
Active
🇫🇷 France
Withings
Reg #: 3008820594
·
FEI: 3008820594
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Withings
- Registration Number
- 3008820594
- FEI Number
- 3008820594
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 rue Maurice Hartmann
- City
- Issy-les-Moulineaux Ile-de-France
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K131395
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 |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-06-10 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device