FDA Device Establishments · JSON-LD · Markdown
FEI 3009758186 · Manufacture Medical Device · Status: Active
| FEI Number | 3009758186 |
|---|---|
| Owner / Operator | SAMSUNG MEDISON CO., LTD. (#8041160) |
| Address | 244, 1gongdan-ro, Gumi-si Gyeongbuk, 39376, 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 | SONOACE R5 |
Source: openFDA. Public-domain (CC0).