FDA Device Establishments · JSON-LD · Markdown
FEI 3011878253 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3011878253 |
|---|---|
| Owner / Operator | ubio Biotechnology Systems Pvt Ltd (#10089502) |
| Address | ubio Biotechnology Systems Pvt ltd, #15A Biotechnology Zone, Kinfra Hi-Tech Park, Kalamassery Kerala, 683503, IN |
| Mandatory US Agent | TechLink International LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NGE |
| Regulation § (21 CFR) | 862.1485 |
| Proprietary names | Inito Fertility Monitor Strip; Fertility Strip |
Source: openFDA. Public-domain (CC0).