FDA Device Establishments · JSON-LD · Markdown
FEI 3014674517 · Manufacture Medical Device · Status: Active
| FEI Number | 3014674517 |
|---|---|
| Owner / Operator | Somnics, Inc. (#10058120) |
| Address | 5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,, Zhubei City Hsinchu, 30261, TW |
| Mandatory US Agent | Dynamic Biotech Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OZR |
| Regulation § (21 CFR) | 872.5570 |
| Proprietary names | The iNAP One Sleep Therapy System |
Source: openFDA. Public-domain (CC0).