FDA Device Establishments · JSON-LD · Markdown
FEI 3026048380 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3026048380 |
|---|---|
| Owner / Operator | GN Hearing A/S (#2182204) |
| Address | No. 18, Jalan Kargo 2, Senai Airport City, Senai Johor, 81400, MY |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ESD |
| Regulation § (21 CFR) | 874.3300 |
| Proprietary names | Peak Pro 9; Bold; AGXR-L; Promise; Origin; OMNIA; Solus Pro; Transducer module with receiver in the ear; Cala; CS Smart Fit |
Source: openFDA. Public-domain (CC0).