FDA Device Establishments · JSON-LD · Markdown
FEI 3006657376 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3006657376 |
|---|---|
| Owner / Operator | Kaesung Co., Ltd. (#10032267) |
| Address | 33, 246 Beon-gil, Bucheon-ro, Wonmi-gu, Bucheon-Si Gyeonggi, 420-806, KR |
| Mandatory US Agent | A-M Systems |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | CAH |
| Regulation § (21 CFR) | 868.5260 |
| Proprietary names | HydroMax HME Filter |
Source: openFDA. Public-domain (CC0).