FDA Device Establishments · JSON-LD · Markdown
FEI 3012936513 · Manufacture Medical Device · Status: Active
| FEI Number | 3012936513 |
|---|---|
| Owner / Operator | MEDICALPARK CO. LTD (#10059444) |
| Address | 7, Saneop-ro 156beon-gil, Gwonseon-gu,, Suwon-si Gyeonggi, 1084, KR |
| Mandatory US Agent | Mtech Group LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | FCG, KNW |
| Regulation § (21 CFR) | 876.1075 |
| Proprietary names | BEXCORE Vacuum Assisted Breast Biopsy System; BXC135, BXC140, BXC145 Biopsy Needles |
Source: openFDA. Public-domain (CC0).