Medical immunosecurity measurement device
์๋ฃ์ฉ๋ฉด์ญ๋นํ์ธก์ ์ฅ์น
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. 20-1818. Approved on Jul 30, 2020. Registered by Mast Bio Co., Ltd..
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MFDS Official Data
Class I
Basic Information
Item Serial Number
2020004822
License Number
In Vitro Reception No. 20-1818
์ฒด์ธ์์ 20-1818ํธ
Classification Number
K01040.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Medical immunosecurity measurement device
์๋ฃ์ฉ๋ฉด์ญ๋นํ์ธก์ ์ฅ์น
Official English Name
Immunonephelometry analyzer
Company Information
Entity Address
๊ฒฝ๊ธฐ๋ ์ฑ๋จ์ ์์ ๊ตฌ ์ฒญ๊ณ์ฐ๋ก 734 5์ธต(๊ณ ๋ฑ๋, ๋ง์คํธ๋น๋ฉ)
Manufacturer
GA Generic Assays GmbH
Category
Import business
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Business License Number
์ฒด์ธ ์ 1194 ํธ
Important Dates & Status
Item Approval Date
Jul 30, 2020
Business Permit Date
Feb 07, 2006
Expiration Period
2020-10-08 ~ 2030-11-30
For Export
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Model Information
Model Name
DotDiver2.0
