FDA Device Establishments · JSON-LD · Markdown
FEI 3009611645 · Manufacture Medical Device · Status: Active
| FEI Number | 3009611645 |
|---|---|
| Owner / Operator | Biotem Co., Ltd. (#10057313) |
| Address | # 422, Sasang-ro, Sasang-gu, Busan, 46925, KR |
| Mandatory US Agent | BIOTEM USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DZE, NHA |
| Regulation § (21 CFR) | 872.3640, 872.3630 |
| Proprietary names | Primus Implant System; AR_N Type Implant System |
Source: openFDA. Public-domain (CC0).