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South Korea MFDS registration In Vitro Jane No. 23-4808

Blood glucose test strip for clinical examination

KO: 임상검사용혈당검사지
South Korea flagSouth Korea·Unknown·SDBiosensor Co., Ltd.·Approved Jun 16, 2023
Basic information
Item Serial Number
2023003493
License Number
In Vitro Jane No. 23-4808
체외제인23-4808호
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)
SDBiosensor Co., Ltd.
에스디바이오센서(주)
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 4413 호
Important dates & status
Item Approval Date
Jun 16, 2023
Business Permit Date
Jan 10, 2014
Model information
Model Name
STANDARD™ GlucoNavii® Elite Blood Glucose Test Strip (01GS100D)
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. 23-4808. Approved on Jun 16, 2023. Registered by SDBiosensor Co., Ltd..

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