FDA Device Establishments · JSON-LD · Markdown
FEI 3032579106 · Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3032579106 |
|---|---|
| Owner / Operator | DEMANT A/S (#8010048) |
| Address | 2720 Chemin St Bernard, Vallauris Alpes-Maritimes, 06220, FR |
| Mandatory US Agent | OTICON MEDICAL LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PFO |
| Regulation § (21 CFR) | 874.3340 |
| Proprietary names | Genie Medical BAHS 2023.1; Sentio 1 Mini, TC; Sentio 1 Mini, CNB; Sentio 1 Mini, DBL; Sentio Position Marker, non-sterile; Sentio Ti Implant Kit; Spare Fixation Screws; Sentio 1 Mini, SIL; Genie Medical BAHS 2024.2; Screwdriver HexaDrive |
Source: openFDA. Public-domain (CC0).