FDA Registration
Active
🇮🇹 Italy
BIOKOSMES SRL
Reg #: 3005488444
·
FEI: 3005488444
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- BIOKOSMES SRL
- Registration Number
- 3005488444
- FEI Number
- 3005488444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA DEI LIVELLI 1
- City
- BOSISIO PARINI,LECCO
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K013056
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 |
|---|---|---|---|---|---|
| Oral Wound Dressing | OLR | Class U | Unknown | No | 2005-12-05 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2010-10-29 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2010-10-29 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2023-08-22 |
Proprietary Names
Aloclair Oral Rinse, Canker-X Rincinol Mouth Sore Rinse (Aloclair Oral Rinse)
Promiseb Topical Cream
Nexodyn Antimicrobial Wound Care Solution
Gelclair
Aloclair Oral Gel, Canker-X Mouth Sore Gel (Aloclair Oral Gel)
Aloclair Oral Spray, Canker-X Mouth Sore Spray (Aloclair Oral Spray)
ScarAway Kids Silicone Scar Gel
ScarAway Acne Scars Silicone Gel
ScarAway Silicon Scar Gel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device