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South Korea MFDS registration In Vitro No. 22-360

Personal blood glucose test strip

KO: 개인용혈당검사지
South Korea flagSouth Korea·Unknown·iSense Wonju Factory·Approved May 31, 2022
Basic information
Item Serial Number
2022002849
License Number
In Vitro No. 22-360
체외제허22-360호
Classification Number
J14010.01
Device Class (Risk Classification)
Unknown
Classification Name
Personal blood glucose test strip
개인용혈당검사지
Official English Name
IVD strip for glucose 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
May 31, 2022
Business Permit Date
Feb 05, 2008
Model information
Model Name
alphacheck KetoSens Blood β-Ketone Strip
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 No. 22-360. Approved on May 31, 2022. Registered by iSense Wonju Factory.

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