Data / Medical devices / Italy / Mattioli Engineering Italia SRL
Mattioli Engineering Italia SRL: FDA-registered device maker in Calenzano Firenze, Italy, 1 510(k) clearance
Mattioli Engineering Italia SRL is registered with the FDA (registration 9680612) in Calenzano Firenze, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 14, 2004. 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
- 9680612
- FEI number
- 1000390170
- Address
- Via San Morese 80, Calenzano Firenze, Italy, 50041
- Owner or operator
- MATTIOLI ENGINEERING LTD. (9035865)
- Roles
- Specification developer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Brush, dermabrasion, powered, DEP SYSTEM PRO, Device, iontophoresis, other uses, Transderm Ionto, Transderm Ionto DEP, Ultrapeel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Specification developer | accessdata.fda.gov |
| Device, Iontophoresis, Other Uses | EGJ | 2 | 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 |
|---|---|---|---|---|---|---|
| October 14, 2004 | K042590 | TRANSDERM IONTO SYSTEM, MK 2 | EGJ | Substantially Equivalent | Mattioli Engineering Corp. | accessdata.fda.gov |
Compare with other makers
Updated October 14, 2004. 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.