Clinical Examination Universal Quality Control Substance I.
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This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In Vitro Reception No. 19-2127. Approved on Aug 26, 2019. Registered by Dong Aesti Co., Ltd..
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MFDS Official Data
Class I
Basic Information
Item Serial Number
2019005301
License Number
In Vitro Reception No. 19-2127
์ฒด์ธ์์ 19-2127ํธ
Classification Number
J08060.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Clinical Examination Universal Quality Control Substance I.
์์๊ฒ์ฌ๋ฒ์ฉ์ ๋๊ด๋ฆฌ๋ฌผ์งโ
Official English Name
General calibrators, controls or standards, classโ
, for clinical chemistry
Company Information
Entity Address
์์ธํน๋ณ์ ๋๋๋ฌธ๊ตฌ ์ฒํธ๋๋ก 64 (์ฉ๋๋)
Manufacturer
More Diagnostics Inc.
Category
Import business
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Business License Number
์ฒด์ธ ์ 561 ํธ
Important Dates & Status
Item Approval Date
Aug 26, 2019
Business Permit Date
May 16, 2005
Expiration Period
2020-10-08 ~ 2030-09-30
For Export
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Model Information
Model Name
DongA MORE Diagnostics Rap/Tac/CsA Control, Level 1์ธ 2๊ฑด
