Data / Medical devices / Oral Wound Dressing / Italy
FDA-registered makers of Oral Wound Dressing in Italy: 7 establishments
7 establishments in Italy are registered with the FDA to make Oral Wound Dressing (product code OLR). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Oral Wound Dressing
- Product code
- OLR
- Country
- Italy
Makers of Oral Wound Dressing in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alliance Pharma SRL | Milan Lombardy, Italy | Complaint file establishment, Specification developer | 3 | January 13, 2005 | 0 | 0 | 0 | api.fda.gov |
| Biokosmes SRL | Bosisio Parini,Lecco, Italy | Contract manufacturer, Manufacturer | 1 | December 21, 2001 | 0 | 0 | 0 | api.fda.gov |
| Bioplax Italia SRL | Milan Lombardy, Italy | Manufacturer | 1 | April 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ricerfarma SRL | Milano, Italy | Exporter to the US, Specification developer | 1 | March 13, 2007 | 0 | 0 | 0 | api.fda.gov |
| Betafarma S.P.A | Milan Lombardy, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinerga SPA | Gorla Maggiore Varese, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sigmar Italia S.P.A | ALME Bergamo, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.