FDA Device Establishments · JSON-LD · Markdown
FEI 3029904429 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3029904429 |
|---|---|
| Owner / Operator | SmartCardia SA (#10088984) |
| Address | EPFL Innovation Park, Lausanne Vaud, 1015, CH |
| Mandatory US Agent | Steurer Consulting Group |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | DSI, QYX, DRG |
| Regulation § (21 CFR) | 870.1025, 870.2910 |
| Proprietary names | 7L Platform |
Source: openFDA. Public-domain (CC0).