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South Korea MFDS registration In Vitro Jane No. 22-4310

Blood glucose test strip for clinical examination

KO: 임상검사용혈당검사지
South Korea flagSouth Korea·Unknown·iSense Wonju Factory·Approved Apr 20, 2022
Basic information
Item Serial Number
2022002035
License Number
In Vitro Jane No. 22-4310
체외제인22-4310호
Classification Number
J13010.01
Device Class (Risk Classification)
Unknown
Classification Name
Blood glucose test strip for clinical examination
임상검사용혈당검사지
Official English Name
Clinical IVD strip for glucose strip
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
Apr 20, 2022
Business Permit Date
Feb 05, 2008
Model information
Model Name
CareFast Pro Blood Glucose Test 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 Jane No. 22-4310. Approved on Apr 20, 2022. 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.

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