FDA Device Establishments · JSON-LD · Markdown
FEI 3012987001 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3012987001 |
|---|---|
| Owner / Operator | ESAOTE S.P.A. (#8021005) |
| Address | Dr. Nolenslaan 157/J, GM Sittard Limburg, 6136, NL |
| Mandatory US Agent | Esaote North America Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | ITX, IYO, IYN |
| Regulation § (21 CFR) | 892.1570, 892.1560, 892.1550 |
| Proprietary names | ML5 |
Source: openFDA. Public-domain (CC0).