FDA Device Establishments · JSON-LD · Markdown

I-SENS Songdo Factory 2

FEI 3030186688 · Manufacture Medical Device · Status: Active

FEI Number3030186688
Owner / Operatori-SENS, Inc. (#9083763)
Address43-10, Incheon tower-daero 25beon-gil, Yeonsu-gu, lncheon Incheon, 22013, KR
Mandatory US AgentI-SENS USA, INC.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)NBW
Regulation § (21 CFR)862.1345
Proprietary namesGLUCOCARD Shine Express Blood Glucose Monitoring System; GLUCOCARD Shine Connex Blood Glucose Monitoring System; CareSens N Voice Square Blood Glucose Monitoring System

External sources

Source: openFDA. Public-domain (CC0).