FDA Device Establishments · JSON-LD · Markdown
FEI 3005465494 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3005465494 |
|---|---|
| Owner / Operator | DEMANT A/S (#8010048) |
| Address | Kongebakken 9, Smorum Hovedstaden, DK-2765, DK |
| Mandatory US Agent | Oticon Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LRB |
| Regulation § (21 CFR) | 874.3300 |
| Proprietary names | Oticon Get (SBO Hearing); Oticon Ria Pro (SBO Hearing); Oticon Nera2 Pro (SBO Hearing); Bernafon RC-A (SBO Hearing); Oticon Ria2 Pro (SBO Hearing); Oticon Nera2 (SBO Hearing); Sonic Enchant SE (SBO Hearing); Oticon Ria2 (SBO Hearing); Philips HearLink App (SBO Hearing); Oticon Opn (SBO Hearing) |
Source: openFDA. Public-domain (CC0).