FDA Device Establishments · JSON-LD · Markdown
FEI 3007955117 · Manufacture Medical Device · Status: Active
| FEI Number | 3007955117 |
|---|---|
| Owner / Operator | HANCHANG Co., Ltd (#10057970) |
| Address | #301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si Gyeonggi, 14501, KR |
| Mandatory US Agent | IRC USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | NDN, HRX |
| Regulation § (21 CFR) | 888.3027, 888.1100 |
| Proprietary names | SpineKure Kyphoplasty System |
Source: openFDA. Public-domain (CC0).