FDA Device Establishments · JSON-LD · Markdown
FEI 3010289997 · Manufacture Medical Device · Status: Active
| FEI Number | 3010289997 |
|---|---|
| Owner / Operator | SAMSUNG MEDISON CO., LTD. (#8041160) |
| Address | 3366, Hanseo-ro, Nam-myeon, HONGCHEON-GUN Gangwon, 25108, KR |
| Mandatory US Agent | Samsung HME America, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | IYN, IYO, ITX |
| Regulation § (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Proprietary names | HERA W10 Diagnostic Ultrasound System |
Source: openFDA. Public-domain (CC0).