Data / Medical devices / Italy / Biokosmes SRL
Biokosmes SRL: FDA-registered device maker in Bosisio Parini,Lecco, Italy, 1 510(k) clearance
Biokosmes SRL is registered with the FDA (registration 3005488444) in Bosisio Parini,Lecco, Italy. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005488444
- Address
- Via Dei Livelli 1, Bosisio Parini,Lecco, Italy, 23842
- Owner or operator
- BIOKOSMES SRL (9080188)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 5, 2005
- Registered through
- 2026
- Brand names listed
- Aloclair Oral Gel, Canker-X Mouth Sore Gel (Aloclair Oral Gel), Aloclair Oral Rinse, Canker-X Rincinol Mouth Sore Rinse (Aloclair Oral Rinse), Aloclair Oral Spray, Canker-X Mouth Sore Spray (Aloclair Oral Spray), Gelclair, Promiseb Topical Cream, ScarAway Acne Scars Silicone Gel, ScarAway Kids Silicone Scar Gel, ScarAway Silicon Scar Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Contract manufacturer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2001 | K013056 | GELCLAIR CONCENTRATED ORAL GEL | OLR | Substantially Equivalent | Sinclair Pharmaceuticals, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of Dressing, Wound, Drug
- All makers of Oral Wound Dressing
Updated December 21, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.