South Korea MFDS registration In Vitro Reception No. 19-2420

Clinical Examination Universal Quality Control Substance I.

KO: 임상검사범용정도관리물질Ⅰ
South Korea flagSouth Korea·Unknown·Biorad Korea Co., Ltd.·Approved Sep 25, 2019
Basic information
Item Serial Number
2019005945
License Number
In Vitro Reception No. 19-2420
체외수신19-2420호
Classification Number
J08060.01
Device Class (Risk Classification)
Unknown
Classification Name
Clinical Examination Universal Quality Control Substance I.
임상검사범용정도관리물질Ⅰ
Official English Name
General calibrators, controls or standards, classⅠ, for clinical chemistry
Company information
Entity Name (Company)
Biorad Korea Co., Ltd.
한국바이오래드(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 719 호
Important dates & status
Item Approval Date
Sep 25, 2019
Business Permit Date
May 26, 2005
Expiration Period
2020-10-08 ~ 2030-09-30
Model information
Model Name
12001085 Level 1 MiniPak
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. 19-2420. Approved on Sep 25, 2019. Registered by Biorad Korea Co., Ltd..

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