FDA Device Establishments · JSON-LD · Markdown
FEI 3017955833 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3017955833 |
|---|---|
| Owner / Operator | FCU Co., Ltd. (#10082644) |
| Address | 2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, 34014, KR |
| Mandatory US Agent | IRC USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ITX |
| Regulation § (21 CFR) | 892.1570 |
| Proprietary names | SiteRite 9 Cue Probe (SKU 9770803) |
Source: openFDA. Public-domain (CC0).