FDA Device Establishments · JSON-LD · Markdown
FEI 3005621222 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3005621222 |
|---|---|
| Owner / Operator | i-SENS, Inc. (#9083763) |
| Address | 43, Banpo-daero 28-gil, Seocho-gu, SEOUL, 06646, KR |
| Mandatory US Agent | i-SENS USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JIN |
| Regulation § (21 CFR) | 862.1435 |
| Proprietary names | KetoSens Multi Blood ?-Ketone Monitoring System; KetoSens Blood ?-Ketone Monitoring System |
Source: openFDA. Public-domain (CC0).