FDA Device Establishments · JSON-LD · Markdown
FEI 3009761573 · Manufacture Medical Device · Status: Active
| FEI Number | 3009761573 |
|---|---|
| Owner / Operator | KANEKA CORP. (#9005249) |
| Address | 225-1 Aza Deguchi, Yamakita, Yamakita-machi, Ashigara-Kami-gun Kanagawa, 2580113, JP |
| Mandatory US Agent | Kaneka Medical America LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | KRD, HCG |
| Regulation § (21 CFR) | 870.3300, 882.5950 |
| Proprietary names | i-ED COIL; EDG v4 |
Source: openFDA. Public-domain (CC0).