FDA Device Establishments · JSON-LD · Markdown
FEI 3021230777 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3021230777 |
|---|---|
| Owner / Operator | Lunit Inc. (#10076093) |
| Address | 4-8F, 374, Gangnam-daero, Gangnam-gu, Seoul, 06241, KR |
| Mandatory US Agent | Mtech Group LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QDQ |
| Regulation § (21 CFR) | 892.2090 |
| Proprietary names | Lunit INSIGHT MMG |
Source: openFDA. Public-domain (CC0).