FDA Device Establishments · JSON-LD · Markdown
FEI 3010515789 · Manufacture Medical Device · Status: Active
| FEI Number | 3010515789 |
|---|---|
| Owner / Operator | LUCEM Co., Ltd. (#10045131) |
| Address | 10-167, Cheomdangieop 5-ro, Sandong-myeon, Gumi-si Gyeongbuk, 39166, KR |
| Mandatory US Agent | DRGEM USA INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ITY |
| Regulation § (21 CFR) | 892.1760 |
| Proprietary names | DXT-19U; DXT-13L; DXT-11L; LUC-9M; LUC-12M; LUC-10M; LUC-14U; LUC-8M; LUC-11M; LUC-15U |
Source: openFDA. Public-domain (CC0).