FDA Device Establishments · JSON-LD · Markdown
FEI 3003989064 · Manufacture Medical Device · Status: Active
| FEI Number | 3003989064 |
|---|---|
| Owner / Operator | INFINITT Healthcare Co., Ltd. (#9055477) |
| Address | 12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea, SEOUL, 08378, KR |
| Mandatory US Agent | David Smarro |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LLZ |
| Regulation § (21 CFR) | 892.2050 |
| Proprietary names | XELIS Colon; XELIS |
Source: openFDA. Public-domain (CC0).