South Korea MFDS registration In vitro water23-4092

Other In Vitro Diagnostics Related Software II.

KO: 기타체외진단관련소프트웨어Ⅱ
South Korea flagSouth Korea·Unknown·Roche Diagnostics Korea·Approved Feb 16, 2023
Basic information
Item Serial Number
2022003260
License Number
In vitro water23-4092
체외수인23-4092호
Classification Number
P20010.01
Device Class (Risk Classification)
Unknown
Classification Name
Other In Vitro Diagnostics Related Software II.
기타체외진단관련소프트웨어Ⅱ
Official English Name
Other software, classⅡ, for IVD
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
Feb 16, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-02-16 ~ 2028-02-15
Model information
Model Name
uPath enterprise Software
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 water23-4092. Approved on Feb 16, 2023. Registered by Roche Diagnostics Korea.

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