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: SFC, SFN2038, SFS0100.
Among these devices, 27 are declared sterile.
Devices declared under this manufacturer
- SafeR Sting
- SafeR Syringe
- SafeR System 1 ml Syringe - 25G * 25mm Sting
- SafeR System 3 ml Syringe – 23G * 38mm Sting
- SafeR System 5 ml Syringe – 23G * 38mm Sting
Showing 12 of 27 declared devices.
Catalogue references include SFC012525, SFC032338, SFN2038, SFN2132, SFN2338, SFN2516.
European nomenclature codes declared: A0101010101, A02010205.
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 |
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: United States only. Roncadelle Operations Srl is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 2409169 1 | issued | 2027-07-25 |