FDA Device Establishments · JSON-LD · Markdown
FEI 3002806925 · Manufacture Medical Device · Status: Active
| FEI Number | 3002806925 |
|---|---|
| Owner / Operator | ESAOTE S.P.A. (#8021005) |
| Address | VIA DI CACIOLLE 15, FLORENCE Firenze, 50127, IT |
| Mandatory US Agent | Esaote North America, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | ITX, IYN, IYO |
| Regulation § (21 CFR) | 892.1570, 892.1550, 892.1560 |
| Proprietary names | MyLabX6; MyLabX7; 6400 Model |
Source: openFDA. Public-domain (CC0).