FDA Registration
Active
🇮🇹 Italy
Splendor X Alex2
Reg #: 3004940677
·
FEI: 3008108972
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOS S.R.L.
- Registration Number
- 3004940677
- FEI Number
- 3008108972
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA GUIDO ROSSA, 10/12
- City
- VIMODRONE Milano
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K243445
Owner / Operator
- Firm Name
- BIOS S.R.L.
- Operator Number
- 9068895
- Address
- VIA GUIDO ROSSA, 10/12, --
- City
- VIMODRONE (MILAN)
- State
- IT-NOTA
- Postal Code
- I-20090
- Country
- IT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-01-13 |
Proprietary Names
Splendor X Alex2
Splendor X Alex+Nd:YAG
Splendor X Alex
Splendor X Nd:YAG
Establishment Types
Manufacture Medical Device