Pure Global
South Korea MFDS registration In Vitro Drug No. 23-920

Personal blood glucose meter

KO: 개인용혈당측정기
South Korea flagSouth Korea·Unknown·iSense Wonju Factory·Approved Sep 13, 2023
Basic information
Item Serial Number
2023005343
License Number
In Vitro Drug No. 23-920
체외제허23-920호
Classification Number
J04010.01
Device Class (Risk Classification)
Unknown
Classification Name
Personal blood glucose meter
개인용혈당측정기
Official English Name
Blood glucose meter for self test
Company information
Entity Name (Company)
iSense Wonju Factory
(주)아이센스원주공장
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 2624 호
Important dates & status
Item Approval Date
Sep 13, 2023
Business Permit Date
Feb 05, 2008
Model information
Model Name
CareSens N Premier Blood Glucose Monitoring System (GM01AAC_011)
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Drug No. 23-920. Approved on Sep 13, 2023. Registered by iSense Wonju Factory.

Pure Global AI provides free access to comprehensive South Korea MFDS registration data, helping global MedTech companies analyze market presence and regulatory compliance for medical devices in South Korea.

Free DatabasePowered by Pure Global AIMFDS Official DataUnknown