FDA Device Establishments · JSON-LD · Markdown
FEI 3010701628 · Manufacture Medical Device · Status: Active
| FEI Number | 3010701628 |
|---|---|
| Owner / Operator | Telea Electronic Engineering S.r.l. (#10046169) |
| Address | via Leonardo da Vinci 13, Sandrigo Vicenza, 36066, IT |
| Mandatory US Agent | Kuro Medical LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | HRX, GEI |
| Regulation § (21 CFR) | 888.1100, 878.4400 |
| Proprietary names | 2501023, Vesalius MCNplus; 2501019, QUANTUM |
Source: openFDA. Public-domain (CC0).