FDA Registration
Active
🇫🇷 France
WINBACK EUROPA SAS
Reg #: 3022747124
·
FEI: 3022747124
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- WINBACK EUROPA SAS
- Registration Number
- 3022747124
- FEI Number
- 3022747124
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 20 Avenue Victor Hugo
- City
- Biarritz Nouvelle-Aquitaine
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K162828
Owner / Operator
- Firm Name
- Swims SAS
- Operator Number
- 10085110
- Address
- Les Bureaux du Parc
- City
- Villeneuve Loubet
- State
- Alpes-Maritimes
- Postal Code
- 06270
- Country
- FR
- Correspondent
- Clemence Roux
US Agent
- Business Name
- SWIMS America
- Contact Name
- Ramona Von Leden
- Address
- 4 Landmark Sq Ste 500
- City
- Stamford
- State
- CT
- ZIP
- 06901
- Country
- US
- [email protected]
- Phone
- 914 4095773
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2022-05-06 |
Proprietary Names
Winback
Establishment Types
Export Device to the United States But Perform No Other Operation on Device