FDA Device Establishments · JSON-LD · Markdown
FEI 3016445768 · Manufacture Medical Device · Status: Active
| FEI Number | 3016445768 |
|---|---|
| Owner / Operator | Osstem Pharma Co., Ltd. (#10062264) |
| Address | Ga-Dong, Ra-Dong, 13, Neunggil-ro 115beon-gil, Danwon-gu, Ansan-si Gyeonggi, 15420, KR |
| Mandatory US Agent | HIOSSEN, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EFS |
| Regulation § (21 CFR) | 872.6510 |
| Proprietary names | WO-200 Osstem Wopick Cordless Oral Irrigator; WO-300 Osstem Wopick Combo Irrigator & Sonic Toothbrush |
Source: openFDA. Public-domain (CC0).