Data / Medical devices / Italy / Campomats
Campomats: FDA-registered device maker in Riccione Rimini, Italy, 1 510(k) clearance
Campomats is registered with the FDA (registration 3042225401) in Riccione Rimini, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042225401
- Address
- Via Monte Rosa 11, Riccione Rimini, Italy, 47838
- Owner or operator
- CAMPOMATS (10094413)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 27, 2025
- Registered through
- 2026
- Brand names listed
- 1NEED Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 19, 2025 | K243472 | 1NEED Pro | QAI | Substantially Equivalent | Campomats S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2025. 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.