South Korea MFDS registration In vitro water 23-25
High-risk infection immunoassay reagent
KO: 고위험성감염체면역검사시약
South Korea·Class III·Roche Diagnostics Korea·Approved Feb 01, 2023Basic information
- Item Serial Number
- 2023000493
- License Number
- In vitro water 23-25
- Classification Number
- K05030.01(3)
- Device Class (Risk Classification)
- Class III
- Classification Name
- High-risk infection immunoassay reagent
- Official English Name
- IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method
체외수허23-25호
고위험성감염체면역검사시약
Company information
- Entity Address
- 서울특별시 강남구 테헤란로108길 22 , 4층~8층(대치동, 서경빌딩)
- Category
- Import business
- Business License Number
- 체외 제 730 호
수입업
Important dates & status
- Item Approval Date
- Feb 01, 2023
- Business Permit Date
- May 27, 2005
- Expiration Period
- 2023-02-01 ~ 2028-01-31
- For Export
- 아니오
Model information
- Model Name
- 08355258190 1 case
08355258190외 1건
About this record
This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In vitro water 23-25. Approved on Feb 01, 2023. Registered by Roche Diagnostics Korea.
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