FDA Device Establishments · JSON-LD · Markdown
FEI 3031569584 · Manufacture Medical Device · Status: Active
| FEI Number | 3031569584 |
|---|---|
| Owner / Operator | Edgecare Inc. (#10090903) |
| Address | 12F, 8 Yangpyeong-ro 25-gil, Yeongdeungpo-gu Seoul, 07207, KR |
| Mandatory US Agent | KMC USA, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | ITX, QIH, IYO |
| Regulation § (21 CFR) | 892.1570, 892.2050, 892.1560 |
| Proprietary names | EdgeFlow UH10S; EdgeFlow UH10L; EdgeFlow UH10 |
Source: openFDA. Public-domain (CC0).