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South Korea MFDS registration Suin 23-4112

Medical image analysis software

KO: 의료영상분석소프트웨어
South Korea flagSouth Korea·Unknown·Boston Scientific Korea Co., Ltd.·Approved Mar 02, 2023
Basic information
Item Serial Number
2023001128
License Number
Suin 23-4112
수인23-4112호
Classification Number
E11020.02
Device Class (Risk Classification)
Unknown
Classification Name
Medical Image Analysis Software
의료영상 분석 소프트웨어
Official English Name
Medical image, analysis software
Company information
Entity Name (Company)
Boston Scientific Korea Co., Ltd.
보스톤사이언티픽코리아(주)
Category
Import business
수입업
Business License Number
제 384 호
Important dates & status
Item Approval Date
Mar 02, 2023
Business Permit Date
Apr 01, 2005
Expiration Period
2023-03-02 ~ 2028-03-01
Model information
Model Name
Simplicit90Y
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number Suin 23-4112. Approved on Mar 02, 2023. Registered by Boston Scientific Korea Co., Ltd..

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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