FDA Device Establishments · JSON-LD · Markdown
FEI 3006179052 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3006179052 |
|---|---|
| Owner / Operator | Bistos Co., Ltd. (#10023402) |
| Address | 522, Geumeo-ro, Pogok-eup,, Cheoin-gu,, Yongin-si Gyeonggi, 17030, KR |
| Mandatory US Agent | Bistos America |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HGM |
| Regulation § (21 CFR) | 884.2740 |
| Proprietary names | Fetal Doppler; Hi-bebe; BT-200T |
Source: openFDA. Public-domain (CC0).