Data / Medical devices / Italy / Al.chi.mi.a. SRL
Al.chi.mi.a. SRL: FDA-registered device maker in PONTE S. NICOLO Padova, Italy, 3 510(k) clearances
Al.chi.mi.a. SRL is registered with the FDA (registration 3004471819) in PONTE S. NICOLO Padova, Italy. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004471819
- Address
- Viale Austria 14, PONTE S. NICOLO Padova, Italy, 35020
- Owner or operator
- Al.Chi.Mi.A. Srl (9057835)
- Roles
- Manufacturer
- First device listed
- December 20, 2016
- Registered through
- 2026
- Brand names listed
- KERASAVE, KERAVIEW, XTRA4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Corneal Storage Media With Preservatives Including Anti-Fungal | QCW | 2 | Manufacturer | accessdata.fda.gov |
| Media, Corneal Storage | LYX | U | 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 |
|---|---|---|---|---|---|---|
| September 11, 2025 | K251320 | XTRA4 | LYX | Substantially Equivalent | Al.Chi.Mi.A. S.R.L | accessdata.fda.gov |
| May 2, 2022 | DEN200063 | Kerasave | QCW | Unknown | Al.Chi.Mi.A. S.R.L | accessdata.fda.gov |
| September 15, 2016 | K162013 | Eusol-C | LYX | Substantially Equivalent | Al.Chi.Mi.A. S.R.L | accessdata.fda.gov |
Compare with other makers
Updated September 11, 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.