FDA Device Establishments · JSON-LD · Markdown
FEI 3003898943 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3003898943 |
|---|---|
| Owner / Operator | Southern Medical (Pty) Ltd (#9052759) |
| Address | 55 Regency, Route 21 Corporate Park, Irene, Pretoria, IRENE Gauteng, 0062, ZA |
| Mandatory US Agent | Southern Implants North America Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FSM |
| Regulation § (21 CFR) | 878.4800 |
| Proprietary names | Riven Caspar Distractor |
Source: openFDA. Public-domain (CC0).