Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in MexicoLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ColoplastLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Unomedical Device S.A. de C.V. with 1 warning letter. The most recent is a warning letter dated Jan 8, 2026: Warning letter: Method validation, CAPA, Complaint handling.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 8, 2026 | Warning letter: Method validation, CAPA, Complaint handlingCDRH | Warning letters |
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
