FDA Registration
Active
🇮🇹 Italy
A.T.S. Applicazione Tecnologie Speciali s.r.l.
Reg #: 3011347852
·
FEI: 3011347852
·
Expires 2026
Products
3
Proprietary Names
14
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- Registration Number
- 3011347852
- FEI Number
- 3011347852
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Alessandro Volta, 10
- City
- Torre de Roveri Bergamo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K250282
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 Ave
- City
- Niles
- State
- IL
- ZIP
- 60714
- Country
- US
- [email protected]
- Phone
- 847 3946960
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2025-06-24 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-06-24 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2021-07-10 |
Proprietary Names
Persona C HR
OMNISCOP DReam
ARCO FP
Omniscop FP
Persona C
AMRAD Medical Agility Plus
Cyberbloc FP
PRIMO S
ARCO FP-S
OMNISCOP Dream-S
Omniscop FP-S
Persona CS
AMRAD Medical Agility
Cyberbloc FP-S
Establishment Types
Manufacture Medical Device