FDA Device Establishments · JSON-LD · Markdown
FEI 3013735968 · Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3013735968 |
|---|---|
| Owner / Operator | Smilelab Co., Ltd. (#10055410) |
| Address | RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi-do, Republic of Korea, Seongnam-si Gyeonggi, 13211, KR |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | JHI, LCX |
| Regulation § (21 CFR) | 862.1155 |
| Proprietary names | PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST) |
Source: openFDA. Public-domain (CC0).