FDA Device Establishments · JSON-LD · Markdown
FEI 3043532714 · Manufacture Medical Device · Status: Active
| FEI Number | 3043532714 |
|---|---|
| Owner / Operator | Optimedi Co., Ltd. (#10095013) |
| Address | 73 Samwon-ro, Deogyang-gu, Goyang-si Gyeonggi, 10550, KR |
| Mandatory US Agent | KMC USA, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FCL |
| Regulation § (21 CFR) | 876.1075 |
| Proprietary names | OP-FC-21-120-C0, OP-FC-21-160-C0, OP-FC-21-180-C0, OP-FC-21-230-C0; OP-FC-21-120-B1, OP-FC-21-160-B1, OP-FC-21-180-B1, OP-FC-21-230-B1; OP-FC-21-120-B0, OP-FC-21-160-B0, OP-FC-21-180-B0, OP-FC-21-230-B0; OP-FC-23-120-B1, OP-FC-23-160-B1, OP-FC-23-180-B1, OP-FC-23-230-B1; OP-FC-18-120-A0, OP-FC-18-160-A0, OP-FC-18-180-A0, OP-FC-18-230-A0; OP-FC-18-120-B0, OP-FC-18-160-B0, OP-FC-18-180-B0, OP-FC-18-230-B0; OP-FC-18-120-A1, OP-FC-18-160-A1, OP-FC-18-180-A1, OP-FC-18-230-A1; OP-FC-18-120-B2, OP-FC-18-160-B2, OP-FC-18-180-B2, OP-FC-18-230-B2; OP-FC-21-120-B2, OP-FC-21-160-B2, OP-FC-21-180-B2, OP-FC-21-230-B2; OP-FC-18-120-C2, OP-FC-18-160-C2, OP-FC-18-180-C2, OP-FC-18-230-C2 |
Source: openFDA. Public-domain (CC0).