FDA Device Establishments · JSON-LD · Markdown
FEI 3035494481 · Manufacture Medical Device · Status: Active
| FEI Number | 3035494481 |
|---|---|
| Owner / Operator | EDENLUX Corp. (#10092393) |
| Address | 1704-ho 145 Gasandigital 1-ro, Geumcheon-gu, Seoul, 08519, KR |
| Mandatory US Agent | USR CO., LTD |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NXR |
| Regulation § (21 CFR) | 886.1290 |
| Proprietary names | OTUS |
Source: openFDA. Public-domain (CC0).