FDA Device Establishments · JSON-LD · Markdown
FEI 3015615781 · Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3015615781 |
|---|---|
| Owner / Operator | Signum Surgical Limited (#10092825) |
| Address | Signum Surgical Limited, New Docks, Port of Galway, Galway Galway (City), H91NNY6, IE |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QML |
| Regulation § (21 CFR) | 878.4835 |
| Proprietary names | BioHealx Anal Fistula Device |
Source: openFDA. Public-domain (CC0).