FDA Registration
Active
🇮🇹 Italy
Cryo6
Reg #: 3004378299
·
FEI: 3004378299
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUANTA SYSTEM, S.P.A.
- Registration Number
- 3004378299
- FEI Number
- 3004378299
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA ACQUEDOTTO, 109
- City
- SAMARATE Varese
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K060395
Owner / Operator
- Firm Name
- QUANTA SYSTEM, S.P.A.
- Operator Number
- 9057522
- Address
- via Acquedotto 109, --
- City
- Samarate
- State
- Varese
- Postal Code
- 21017
- Country
- IT
- Correspondent
- Dario Bandiera
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-04-05 |
Proprietary Names
Cryo6
Establishment Types
Export Device to the United States But Perform No Other Operation on Device