FDA Registration
Active
🇫🇷 France
KEOPS BALANCE ANALYZER 3D
Reg #: 3015383864
·
FEI: 3015383864
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- S.M.A.I.O
- Registration Number
- 3015383864
- FEI Number
- 3015383864
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Place Berthe Morisot, Parc Technologique
- City
- SAINT-PRIEST Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K213975
Owner / Operator
- Firm Name
- S.M.A.I.O
- Operator Number
- 10077967
- Address
- 2 Place Berthe Morisot, Parc Technologique
- City
- SAINT-PRIEST
- State
- Auvergne-Rhone-Alpes
- Postal Code
- 69800
- Country
- FR
- Correspondent
- Jean-Charles Roussouly
US Agent
- Business Name
- DAWA MEDICAL LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th street suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5999373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-05-23 |
Proprietary Names
KEOPS BALANCE ANALYZER 3D
Establishment Types
Manufacture Medical Device