South Korea MFDS registration In Vitro Reception No. 22-318

Automatic medical separation method clinical chemistry analysis device

KO: 의료용분리방식임상화학자동분석장치
South Korea flagSouth Korea·Class I·JW Bioscience Co., Ltd.·Approved Feb 24, 2022
Basic information
Item Serial Number
2022000971
License Number
In Vitro Reception No. 22-318
체외수신22-318호
Classification Number
J01020.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Automatic medical separation method clinical chemistry analysis device
의료용분리방식임상화학자동분석장치
Official English Name
Clinical chemistry automated analyser
Company information
Entity Name (Company)
JW Bioscience Co., Ltd.
제이더블유바이오사이언스(주)
Entity Address
서울특별시 서초구 남부순환로 2477 9층 일부(서초동)
Manufacturer
JEOL Ltd.
Category
Import business
수입업
Business License Number
체외 제 3842 호
Important dates & status
Item Approval Date
Feb 24, 2022
Business Permit Date
May 19, 2016
Expiration Period
2022-02-24 ~ 2027-02-23
For Export
아니오
Model information
Model Name
JCA-BM8060
About this record

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Reception No. 22-318. Approved on Feb 24, 2022. Registered by JW Bioscience Co., Ltd..

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