South Korea MFDS registration In Vitro Drug No. 24-3

Personal blood glucose test strip

KO: 개인용혈당검사지
South Korea flagSouth Korea·Unknown·iSense Wonju Factory·Approved Jan 02, 2024
Basic information
Item Serial Number
2024000010
License Number
In Vitro Drug No. 24-3
체외제허24-3호
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
Jan 02, 2024
Business Permit Date
Feb 05, 2008
Model information
Model Name
GSD03
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. 24-3. Approved on Jan 02, 2024. 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