Data / Medical devices / Italy / Uniderm Farmaceutici SRL
Uniderm Farmaceutici SRL: FDA-registered device maker in Roma, Italy, 1 510(k) clearance
Uniderm Farmaceutici SRL is registered with the FDA (registration 3004079477) in Roma, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 19, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004079477
- Address
- Viale Enrico Ortolani 211, Roma, Italy, 00125
- Owner or operator
- Uniderm Farmaceutici SRL (10048905)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 18, 2015
- Registered through
- 2026
- Brand names listed
- Lubrigyn Cream
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 19, 2015 | K150147 | Lubrigyn cream | NUC | Substantially Equivalent | Uniderm Farmaceutici Srl | accessdata.fda.gov |
Compare with other makers
Updated February 19, 2015. 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.