FDA Device Establishments · JSON-LD · Markdown
FEI 3013697074 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3013697074 |
|---|---|
| Owner / Operator | SPECLIPSE, Inc. (#10094634) |
| Address | #501, #502, #503, #504, #505, 232 Sandan-ro, Danwon-gu, Ansan-si Gyeonggi, 15433, KR |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEX |
| Regulation § (21 CFR) | 878.4810 |
| Proprietary names | PICOFY; PICO-K |
Source: openFDA. Public-domain (CC0).