FDA Device Establishments · JSON-LD · Markdown
FEI 3014384451 · Manufacture Medical Device · Status: Active
| FEI Number | 3014384451 |
|---|---|
| Owner / Operator | LAMEDITECH Co., Ltd. (#10057401) |
| Address | #1002, ACE High End Tower 6th, Beotkkot-ro-234, Geumcheon-gu, Seoul, 08513, KR |
| Mandatory US Agent | Immunostics Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEX |
| Regulation § (21 CFR) | 878.4810 |
| Proprietary names | HandyRay-Lite (model LMT-1000); HandyRay (model LMT-3000); HandyRay-Pro (model LMT-5000) |
Source: openFDA. Public-domain (CC0).