Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Copan Italia and its 1 subsidiaries with 18 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Oct 11, 2024: UriSponge™.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Copan Italia and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 11, 2024 | UriSponge™K232565 · JSM | 510(k) clearances |
| Apr 25, 2024 | Copan Universal Transport Medium (UTM-RT) SystemK232357 · JSM | 510(k) clearances |
| Jul 14, 2023 | COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.Class II · Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance | Device recalls |
| Dec 16, 2022 | Copan FecalSwab Collection, Transport and Preservation SystemK220052 · JSM | 510(k) clearances |
| Sep 17, 2020 | eNAT molecular collection and preservation mediumK201849 · QBD | 510(k) clearances |
| Mar 23, 2018 | UriSwab-Urine Collection, Transport and Preservation SystemK180052 · JSM | 510(k) clearances |
| Apr 10, 2015 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMK142094 · JSM | 510(k) clearances |
| Jun 23, 2006 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMK061301 · JTW | 510(k) clearances |
| Dec 7, 2004 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMK042970 · JSM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
