Data / Medical devices / Italy / Qualimed SRL
Qualimed SRL: FDA-registered device maker in Gallarate Varese, Italy, 2 510(k) clearances
Qualimed SRL is registered with the FDA (registration 3011553378) in Gallarate Varese, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 13, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011553378
- Address
- Viale dell Unione Europea 8, Gallarate Varese, Italy, 21013
- Owner or operator
- QUALIMED SRL (10048296)
- Roles
- Complaint file establishment
- First device listed
- December 26, 2014
- Registered through
- 2027
- Brand names listed
- ATTITUDE, DESIO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 13, 2018 | K181050 | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | LPL | Substantially Equivalent | Qualimed Srl | accessdata.fda.gov |
| December 12, 2014 | K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | LPL | Substantially Equivalent | Qualimed Srl | accessdata.fda.gov |
Compare with other makers
Updated June 13, 2018. 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.