FDA Device Establishments · JSON-LD · Markdown
FEI 3014337591 · Repack or Relabel Medical Device · Status: Active
| FEI Number | 3014337591 |
|---|---|
| Owner / Operator | hearX (#10057906) |
| Address | Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens, Pretoria Gauteng, 0081, ZA |
| Mandatory US Agent | FDAbasics LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QUH |
| Regulation § (21 CFR) | 874.3325 |
| Proprietary names | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application |
Source: openFDA. Public-domain (CC0).