Real-time gene amplification device
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This Class II medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In vitro water22-4145. Approved on Mar 21, 2022. Registered by Mast Bio Co., Ltd..
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MFDS Official Data
Class II
Basic Information
Item Serial Number
2022001427
License Number
In vitro water22-4145
์ฒด์ธ์์ธ22-4145ํธ
Classification Number
N01030.01(2)
Device Class (Risk Classification)
Class II
Classification Name
Real-time gene amplification device
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Official English Name
Real-time gene amplificator, nucleic acid
Company Information
Entity Address
๊ฒฝ๊ธฐ๋ ์ฑ๋จ์ ์์ ๊ตฌ ์ฒญ๊ณ์ฐ๋ก 734 5์ธต(๊ณ ๋ฑ๋, ๋ง์คํธ๋น๋ฉ)
Manufacturer
DIATRON MI Plc
Category
Import business
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Business License Number
์ฒด์ธ ์ 1194 ํธ
Important Dates & Status
Item Approval Date
Mar 21, 2022
Business Permit Date
Feb 07, 2006
Expiration Period
2022-03-21 ~ 2027-03-20
For Export
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Model Information
Model Name
MOL1011
