FDA Device Establishments · JSON-LD · Markdown
FEI 3018448099 · Manufacture Medical Device · Status: Active
| FEI Number | 3018448099 |
|---|---|
| Owner / Operator | HANIL MEDICAL CO., LTD. (#10081266) |
| Address | 147-58, Baekgogae-gil, Gonjiam-eup, Gwangju-si, 12806, KR |
| Mandatory US Agent | LK Consulting Group USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ISA |
| Regulation § (21 CFR) | 890.5660 |
| Proprietary names | HEALAX i Shoulder |
Source: openFDA. Public-domain (CC0).