510(k) Report

FDA applicant

Uniderm Farmaceutici Srl

Imola, Bo, IT2 decisions2014–20150 recalls

FDA records 2 decisions for Uniderm Farmaceutici Srl (Imola, Bo, IT) from 2014 to 2015: 2 510(k) clearances. All are in product code NUC (Lubricant, Personal). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Uniderm Farmaceutici Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Uniderm Farmaceutici Srl by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Uniderm Farmaceutici Srl’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NUCLubricant, Personal2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132772Lubrigyn CreamUniderm Farmaceutici Srl · 20141cites it

What has FDA decided for it lately?

  • K150147Lubrigyn creamUniderm Farmaceutici Srl · 2015
  • K132772Lubrigyn CreamUniderm Farmaceutici Srl · 2014

All 2 as Uniderm Farmaceutici Srl →