FDA Registration
Active
🇲🇨 Monaco
ECHOLASER X4
Reg #: 3016096097
·
FEI: 3016096097
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROCAMED SAM
- Registration Number
- 3016096097
- FEI Number
- 3016096097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Avenue Albert II, Le copori
- City
- MONACO Monaco-Ville
- Country
- MC
Regulatory Submissions
- 510(k) Number
- K213594
Owner / Operator
- Firm Name
- ROCAMED SAM
- Operator Number
- 10092141
- Address
- 9 Av Albert II
- City
- MONACO
- State
- Monaco-Ville
- Postal Code
- 98000
- Country
- MC
- Correspondent
- Erica Tartaglione
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-12-09 |
Proprietary Names
ECHOLASER X4
Establishment Types
Export Device to the United States But Perform No Other Operation on Device