FDA Device Establishments · JSON-LD · Markdown
FEI 3034246184 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3034246184 |
|---|---|
| Owner / Operator | Brightonix Imaging Inc. (#10091856) |
| Address | #B203, #409, Seongsu AK Valley, 76, Yeonmujang-gil, Seongdong-gu, Seoul, 04784, KR |
| Mandatory US Agent | Mtech Group LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KPS |
| Regulation § (21 CFR) | 892.1200 |
| Proprietary names | PHAROS |
Source: openFDA. Public-domain (CC0).