FDA Registration
Active
🇮🇹 Italy
PRIMO S
Reg #: 3011347852
·
FEI: 3011347852
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- Registration Number
- 3011347852
- FEI Number
- 3011347852
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Alessandro Volta, 10
- City
- Torre de Roveri Bergamo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K211542
Owner / Operator
- Firm Name
- SEDECAL S.A.
- Operator Number
- 9039772
- Address
- PELAYA, 9 POL., POL. IND. "RIO DE JANEIRO"
- City
- ALGETE
- State
- Madrid (Province)
- Postal Code
- 28110
- Country
- ES
US Agent
- Business Name
- SEDECAL USA, INC
- Contact Name
- Devan Moser
- Address
- 7555 N. Caldwell Avenue
- City
- Niles
- State
- IL
- ZIP
- 60714
- Country
- US
- [email protected]
- Phone
- 847 3946960
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2021-07-10 |
Proprietary Names
PRIMO S
Establishment Types
Manufacture Medical Device