Data / Medical devices / Italy / Metaltronica Spa
Metaltronica Spa: FDA-registered device maker in Pomezia Roma, Italy, 1 510(k) clearance
Metaltronica Spa is registered with the FDA (registration 3009868110) in Pomezia Roma, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009868110
- Address
- Pomezia (RM) via delle Monachelle 66, Pomezia Roma, Italy, 00071
- Owner or operator
- SEDECAL S.A. (9039772)
- Roles
- Manufacturer
- First device listed
- October 5, 2023
- Registered through
- 2026
- Brand names listed
- Helianthus, Serenys DR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 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 15, 2021 | K202822 | Helianthus | MUE | Substantially Equivalent | Metaltronica Spa | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2021. 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.