FDA Device Establishments · JSON-LD · Markdown
FEI 3017441596 · Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3017441596 |
|---|---|
| Owner / Operator | DEMANT A/S (#8010048) |
| Address | Boulevard Corredor Tijuana-Rosarito 2000, #24702 H-1, Ejido Francisco Villa, Tijuana Baja California, 22235, MX |
| Mandatory US Agent | Oticon Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ESD |
| Regulation § (21 CFR) | 874.3300 |
| Proprietary names | Oticon Own SI (SBO Hearing); Easy LE Adapter (Bernafon); BERNAFON; AudigyFit 2 (SBO Hearing); Bernafon Oasisnxt (SBO Hearing); Oticon Genie 2 (SBO Hearing); AGXO F (SBO Hearing); Bernafon Encanta (SBO Hearing); Bernafon Entra B (SBO Hearing); Oticon SmartCharger miniBTE R (SBO Hearing) |
Source: openFDA. Public-domain (CC0).