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: M079A1, M079C1, M104G1, M116A1, M126E1.
Among these devices, 104 are declared active.
Devices declared under this manufacturer
- AGAIN
- GALILEO
- HiScan
- HiScan DOT/RF
- HiScan V2LR
- MOTUS AZ+
- MOTUS PRO
- ONDA
- SMART US-20 D
- SMARTXIDE
- SYNCHRO REPLA:Y Premium 2.4.2
- SmartXide Punto 30
Showing 12 of 157 declared devices.
Catalogue references include E124G2, F26901, M118A1, M126E1, M126F1, M130F1.
European nomenclature codes declared: Z12011099, Z12011019, Z12011005, Z12011017, Z12011012, Z12040202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 157 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 157 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 1.9 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. DEKA M.E.L.A. SRL was not found in either the U.S. or the Canadian register.
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 |