FDA Device Establishments · JSON-LD · Markdown
FEI 3038290392 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3038290392 |
|---|---|
| Owner / Operator | Inito Health Tech Private Limited (#10093348) |
| Address | No. 4, Indiqube Prism, 1st, 2nd & 3rd Floor, Industrial Layout, Koramangala Extension, Koramangala VI Bk, Bangalore, Bangalore South Karnataka, 560095, IN |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NGE |
| Regulation § (21 CFR) | 862.1485 |
| Proprietary names | Inito Fertility Tracker - InSight Reader / Inito Fertility Monitor; InSight Wireless Reader; Fertility Strip / Inito Fertility Monitor Strip |
Source: openFDA. Public-domain (CC0).