FDA Device Establishments · JSON-LD · Markdown
FEI 3013177549 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3013177549 |
|---|---|
| Owner / Operator | COCHLEAR AMERICAS (#9076254) |
| Address | Unit UG-1, Upper Ground Floor, Vertical Podium, The Vertical, Avenue 3, Bangsar South, No 8 Jalan Kerinchi, Kuala Lumpur Kuala Lumpur, 59200, MY |
| Mandatory US Agent | Cochlear Americas |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PFO |
| Regulation § (21 CFR) | 874.3340 |
| Proprietary names | Cochlear OsiaTM System |
Source: openFDA. Public-domain (CC0).