Data / Medical devices / Electrode, Cutaneous / Italy
FDA-registered makers of Electrode, Cutaneous in Italy: 5 establishments
5 establishments in Italy are registered with the FDA to make Electrode, Cutaneous (product code GXY). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Electrode, Cutaneous
- Product code
- GXY
- Country
- Italy
Makers of Electrode, Cutaneous in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bionit Labs S.R.L. | Soleto Lecce, Italy | Complaint file establishment, Manufacturer | 2 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spes Medica S.P.A | Genova Liguria, Italy | Exporter to the US, Manufacturer | 2 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Spes Medica S.P.A | BATTIPAGLIA Salerno, Italy | Exporter to the US, Manufacturer | 2 | June 11, 2012 | 0 | 0 | 0 | api.fda.gov |
| Domino S.R.L. | Codogne Treviso, Italy | Manufacturer | 1 | May 9, 1997 | 0 | 0 | 0 | api.fda.gov |
| Fiab SPA | Vicchio Firenze, Italy | Manufacturer | 1 | July 22, 2009 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.