FDA Device Establishments · JSON-LD · Markdown
FEI 3016842138 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3016842138 |
|---|---|
| Owner / Operator | Hukui Biotechnology Co., Ltd. (#10090863) |
| Address | 8F-1 & 2, No.1, Huanke 1st Rd., Zhubei City Hsinchu, 302047, TW |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | IYO, IYN, ITX |
| Regulation § (21 CFR) | 892.1560, 892.1550, 892.1570 |
| Proprietary names | LELTEK Ultrasound Imaging System |
Source: openFDA. Public-domain (CC0).