Data / Medical devices / Italy / Roncadelle Operations SRL
Roncadelle Operations SRL: FDA-registered device maker in Castel Mella Brescia, Italy, 1 510(k) clearance
Roncadelle Operations SRL is registered with the FDA (registration 3027338968) in Castel Mella Brescia, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3027338968
- Address
- Via Renolda 10, Castel Mella Brescia, Italy, 25030
- Owner or operator
- Roncadelle Operations srl (10087104)
- Roles
- Manufacturer
- First device listed
- May 22, 2023
- Registered through
- 2026
- Brand names listed
- SafeR Syringe and SafeR Sting
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 29, 2022 | K221981 | SafeR Syringe and SafeR Sting | MEG | Substantially Equivalent | Roncadelle Operations Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
Updated December 29, 2022. 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.