FDA Device Establishments · JSON-LD · Markdown
FEI 3010879605 · Manufacture Medical Device · Status: Active
| FEI Number | 3010879605 |
|---|---|
| Owner / Operator | Sugentech, Inc. (#10046776) |
| Address | 721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk, 28161, KR |
| Mandatory US Agent | IRC USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LCX |
| Regulation § (21 CFR) | 862.1155 |
| Proprietary names | Surearly Digital Pregnancy Test; Surearly Pregnancy Test Strip |
Source: openFDA. Public-domain (CC0).