FDA Registration
Active
🇮🇹 Italy
BIOS S.R.L.
Reg #: 3004940677
·
FEI: 3008108972
·
Expires 2026
Products
4
Proprietary Names
15
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOS S.R.L.
- Registration Number
- 3004940677
- FEI Number
- 3008108972
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA GUIDO ROSSA, 10/12
- City
- VIMODRONE Milano
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K241407
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 | 2024-06-27 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2021-10-29 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-12-06 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-12-06 |
Proprietary Names
Splendor X Nd:YAG
Splendor X Alex2
Splendor X Alex+Nd:YAG
Splendor X Alex
NuEra Tight 1ch
SQUARE EPIL Nd:YAG
SQUARE EPIL ALEX2
SQUARE EPIL ALEX + Nd:YAG
SQUARE EPIL ALEX
SPLENDOR X ALEX + Nd:YAG
SPLENDOR X ALEX
SPLENDOR X Nd:YAG
SPLENDOR X ALEX2
NuEra Tight RF
NuEra Tight RF Plus
Establishment Types
Manufacture Medical Device