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South Korea MFDS registration In Vitro Water No. 23-244

Pathology Tissue Diagnosis Assistant Software II

KO: 병리조직진단보조소프트웨어II
South Korea flagSouth Korea·Unknown·Roche Diagnostics Korea·Approved Jun 23, 2023
Basic information
Item Serial Number
2023003614
License Number
In Vitro Water No. 23-244
체외수허23-244호
Classification Number
P04010.01
Device Class (Risk Classification)
Unknown
Classification Name
Pathology Tissue Diagnosis Assistant Software II
병리조직진단보조소프트웨어II
Official English Name
Computer aided diagnosis software for pathological cells or tissue
Company information
Entity Name (Company)
Roche Diagnostics Korea
한국로슈진단(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 730 호
Important dates & status
Item Approval Date
Jun 23, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-06-23 ~ 2028-06-22
Model information
Model Name
uPath HER2 (4B5) image analysis for Breast Algorithm
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 Water No. 23-244. Approved on Jun 23, 2023. Registered by Roche Diagnostics Korea.

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