FDA Device Establishments · JSON-LD · Markdown
FEI 3011213605 · Manufacture Medical Device · Status: Active
| FEI Number | 3011213605 |
|---|---|
| Owner / Operator | i-SENS, Inc. (#9083763) |
| Address | 12, Harmony-ro 275beon-gil, Yeonsu-gu,, Incheon, 22014, KR |
| Mandatory US Agent | i-SENS USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NBW |
| Regulation § (21 CFR) | 862.1345 |
| Proprietary names | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System; ReliOn Premier BLU Blood Glucose Monitoring System |
Source: openFDA. Public-domain (CC0).