FDA Device Establishments · JSON-LD · Markdown
FEI 3007037208 · Remanufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3007037208 |
|---|---|
| Owner / Operator | Hanwei Electronics Group (#10033905) |
| Address | No.169, Xuesong Road, National Hi-Tech Zone, Zhengzhou Henan, 450001, CN |
| Mandatory US Agent | KHN Solutions LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DJZ |
| Regulation § (21 CFR) | 862.3050 |
| Proprietary names | Alcohol Tester, Breathalyzer; Breathalyzer AT218; Breathalyzer AT8030; Breathalyzer AT188; Breathalyzer AT7300; Breathalyzer AT800; Breathalyzer AT8020; Breathalyzer AT202; Breathalyzer AT198; Breathalyzer AT8060 |
Source: openFDA. Public-domain (CC0).