# i-SENS Songdo Factory

FEI: 3011213605
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: i-SENS, Inc. (#9083763)

Address: 12, Harmony-ro 275beon-gil, Yeonsu-gu,, Incheon, 22014, KR

Mandatory US Agent: i-SENS USA, Inc.

## Products

Total registered: 1
Top product codes: NBW
Regulation §: 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: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223011213605%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3011213605