South Korea MFDS registration In Vitro Reception No. 17-182

Automatic medical separation method clinical chemistry analysis device

KO: 의료용분리방식임상화학자동분석장치
South Korea flagSouth Korea·Class I·Dong Aesti Co., Ltd.·Approved Jan 19, 2017
Basic information
Item Serial Number
2017000375
License Number
In Vitro Reception No. 17-182
체외수신17-182호
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)
Dong Aesti Co., Ltd.
동아에스티(주)
Entity Address
서울특별시 동대문구 천호대로 64 (용두동)
Manufacturer
Thermo Fisher Scientific Oy
Category
Import business
수입업
Business License Number
체외 제 561 호
Important dates & status
Item Approval Date
Jan 19, 2017
Business Permit Date
May 16, 2005
Expiration Period
2020-10-08 ~ 2030-02-28
For Export
아니오
Model information
Model Name
Indiko
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. 17-182. Approved on Jan 19, 2017. Registered by Dong Aesti Co., Ltd..

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