FDA Registration
Active
🇮🇹 Italy
CLISIS SYSTEMS
Reg #: 8020997
·
FEI: 3002807092
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GENERAL MEDICAL MERATE S.P.A.
- Registration Number
- 8020997
- FEI Number
- 3002807092
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA PARTIGIANI, 25
- City
- SERIATE, BERGAMO
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K213081
Owner / Operator
- Firm Name
- GENERAL MEDICAL MERATE S.P.A.
- Operator Number
- 8020997
- Address
- VIA PARTIGIANI, 25, --
- City
- SERIATE, BERGAMO
- State
- IT-NOTA
- Postal Code
- 24068
- Country
- IT
- Correspondent
- Luca - Bianchessi
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomographic | IZF | Class 2 | Radiology | No | 2021-12-15 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2021-12-15 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 2021-12-15 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2021-12-15 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2021-12-15 |
Proprietary Names
CLISIS SYSTEMS
Discovery RF180
Establishment Types
Manufacture Medical Device