FDA Registration
Active
🇮🇹 Italy
ScarAway Silicon Scar Gel
Reg #: 3005488444
·
FEI: 3005488444
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOKOSMES SRL
- Registration Number
- 3005488444
- FEI Number
- 3005488444
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA DEI LIVELLI 1
- City
- BOSISIO PARINI,LECCO
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K002488
Owner / Operator
- Firm Name
- BIOKOSMES SRL
- Operator Number
- 9080188
- Address
- Via Dei Livelli 1
- City
- Bosisio Parini,Lecco
- State
- IT-LC
- Postal Code
- 23842
- Country
- IT
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2023-08-22 |
Proprietary Names
ScarAway Silicon Scar Gel
ScarAway Kids Silicone Scar Gel
ScarAway Acne Scars Silicone Gel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)