South Korea MFDS registration In vitro water 22-288

Blood Transfusion Medical General-purpose Quality Control Substance

KO: 수혈의학범용정도관리물질
South Korea flagSouth Korea·Class III·Biorad Korea Co., Ltd.·Approved Dec 16, 2022
Basic information
Item Serial Number
2022006465
License Number
In vitro water 22-288
체외수허22-288호
Classification Number
L02060.03(3)
Device Class (Risk Classification)
Class III
Classification Name
Blood Transfusion Medical General-purpose Quality Control Substance
수혈의학범용정도관리물질
Official English Name
General calibrators, controls or standards, class Ⅲ, for blood transfusion
Company information
Entity Name (Company)
Biorad Korea Co., Ltd.
한국바이오래드(주)
Entity Address
서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
Manufacturer
Bio-Rad Medical Diagnostics GmbH
Category
Import business
수입업
Business License Number
체외 제 719 호
Important dates & status
Item Approval Date
Dec 16, 2022
Business Permit Date
May 26, 2005
Expiration Period
2022-12-16 ~ 2027-12-15
For Export
아니오
Model information
Model Name
816030
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 22-288. Approved on Dec 16, 2022. Registered by Biorad Korea Co., Ltd..

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