FDA Device Establishments · JSON-LD · Markdown
FEI 3034532468 · Manufacture Medical Device · Status: Active
| FEI Number | 3034532468 |
|---|---|
| Owner / Operator | ACTIS MEDICAL (#10092149) |
| Address | 18 Dequetteville Terrace, Kent Town South Australia, 5067, AU |
| Mandatory US Agent | Aztech Regulatory and Quality LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LXH |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | A3 Access Drill Kit - Manual Orthopedic Instruments |
Source: openFDA. Public-domain (CC0).