Roncadelle Operations Srl
IT-MF-000017979 · Italy · Castel Mella
Roncadelle Operations Srl is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 27 |
|---|
Most frequent device types declared: SFN2038, SFS0100, SFC.
Among these devices, 27 are declared sterile.
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 | Registered with FDA |
|---|---|
| Matched entry | RONCADELLE OPERATIONS SRL (IT) · FDA 3027338968 |
| Devices in EUDAMED | 27 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 2409169 1 | issued | 2027-07-25 |