FDA Device Establishments · JSON-LD · Markdown
FEI 3031493119 · Manufacture Medical Device · Status: Active
| FEI Number | 3031493119 |
|---|---|
| Owner / Operator | Izenimplant Co., Ltd. (#10080021) |
| Address | 30, Jeongnamsandan 1-gil, Jeongnam-myeon, Hwaseong-si Gyeonggi, 18514, KR |
| Mandatory US Agent | Withus Group Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | NHA, DZE |
| Regulation § (21 CFR) | 872.3630, 872.3640 |
| Proprietary names | ZENEX Implant System |
Source: openFDA. Public-domain (CC0).