FDA Device Establishments · JSON-LD · Markdown
FEI 3038610665 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3038610665 |
|---|---|
| Owner / Operator | Hochuen Medical Sdn. Bhd. (#10093449) |
| Address | 62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC, SENAI Johor, 81400, MY |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 10 |
| Product codes (top 20) | OZX, OOU, OQW, OZY, NSU, OCC, OEM, OZE, OTG, OEP |
| Regulation § (21 CFR) | 866.3980, 866.3332, 862.2570 |
| Proprietary names | ePlex® Respiratory Pathogen (RP) Panel |
Source: openFDA. Public-domain (CC0).