Data / Medical devices / Spain / Bio Cosmetics S.L.
Bio Cosmetics S.L.: FDA-registered device maker in Madrid Madrid(Province), Spain, 2 510(k) clearances
Bio Cosmetics S.L. is registered with the FDA (registration 3008826993) in Madrid Madrid(Province), Spain. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 14, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008826993
- Address
- Calle Araquil 11, Madrid Madrid(Province), Spain, 28023
- Owner or operator
- BIO COSMETICS S.L. (10044501)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 20, 2013
- Registered through
- 2026
- Brand names listed
- "AIR LIFT/XEROSTOM" ARTIFICIAL SALIVA, XEROSTOM, XEROSTOM SALIVA SUBSTITUTE GEL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Saliva, Artificial | LFD | 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 |
|---|---|---|---|---|---|---|
| September 14, 2015 | K142657 | XEROSTOM SALIVA SUBSTITUTE GEL | LFD | Substantially Equivalent | Bio Cosmetics, S.L. | accessdata.fda.gov |
| June 6, 2012 | K120552 | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA | LFD | Substantially Equivalent | Biocosmetics Laboratories | accessdata.fda.gov |
Compare with other makers
Updated September 14, 2015. 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.