DEKA M.E.L.A. SRL
IT-MF-000007389 · Italy · Calenzano (FI)
DEKA M.E.L.A. SRL is registered in the European database on medical devices as a manufacturer, with 157 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 150 |
|---|---|
| Class IIa | 7 |
Most frequent device types declared: M130H1, M130L1, M126E1, M126F1, M130F1.
Among these devices, 104 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 157 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 098416 0015 | reissued | 2031-09-20 |
G10 098416 0009 | issued | 2026-09-20 |
277/MDR | issued | 2031-05-18 |