FDA Device Establishments · JSON-LD · Markdown
FEI 3008950127 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3008950127 |
|---|---|
| Owner / Operator | Alpinion Medical Systems Co., Ltd. (#10037469) |
| Address | 4F, 15, Magokjungang 14-ro, Gangseo-gu Seoul, 07789, KR |
| Mandatory US Agent | ALPINION USA |
| 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 | L3-12HWD; SP3-8T; L8-17H; SP1-5T; IO8-17T; L3-12T; EV3-10T; E-CUBE i7; L3-8H; VC1-6T |
Source: openFDA. Public-domain (CC0).