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South Korea MFDS registration In Vitro Reception No. 24-85

Medical enzyme immunoassay device

KO: 의료용효소면역검사장치
South Korea flagSouth Korea·Unknown·Mast Bio Co., Ltd.·Approved Jan 18, 2024
Basic information
Item Serial Number
2024000317
License Number
In Vitro Reception No. 24-85
체외수신24-85호
Classification Number
K01010.01
Device Class (Risk Classification)
Unknown
Classification Name
Medical enzyme immunoassay device
의료용효소면역검사장치
Official English Name
Enzyme immunoassay/ELISA analyzer
Company information
Entity Name (Company)
Mast Bio Co., Ltd.
마스트바이오(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 1194 호
Important dates & status
Item Approval Date
Jan 18, 2024
Business Permit Date
Feb 07, 2006
Expiration Period
2024-01-18 ~ 2029-01-17
Model information
Model Name
ChemWell 2
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 Reception No. 24-85. Approved on Jan 18, 2024. Registered by Mast Bio Co., Ltd..

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