FDA Device Establishments · JSON-LD · Markdown
FEI 3012239564 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3012239564 |
|---|---|
| Owner / Operator | BlueWind Medical Ltd. (#10088572) |
| Address | 6 Maskit Street, Herzliya Tel Aviv, 4614002, IL |
| Mandatory US Agent | BlueWind Medical |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QXM |
| Regulation § (21 CFR) | 876.5305 |
| Proprietary names | Revi Implant; Revi Clinician Program; Revi System; Revi Wearable; Revi Hub |
Source: openFDA. Public-domain (CC0).