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Medical immunofluorescence measurement device

์˜๋ฃŒ์šฉ๋ฉด์—ญํ˜•๊ด‘์ธก์ •์žฅ์น˜

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number In Vitro Reception No. 21-392. Approved on Mar 11, 2021. Registered by Mast Bio Co., Ltd..

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MFDS Official Data
Class I
Basic Information
Item Serial Number
2021001238
License Number
In Vitro Reception No. 21-392
์ฒด์™ธ์ˆ˜์‹ 21-392ํ˜ธ
Classification Number
K01020.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Medical immunofluorescence measurement device
์˜๋ฃŒ์šฉ๋ฉด์—ญํ˜•๊ด‘์ธก์ •์žฅ์น˜
Official English Name
Fluorimetric immunoassay analyzer(FIA), stationary
Company Information
Entity Name (Company)
Mast Bio Co., Ltd.
๋งˆ์ŠคํŠธ๋ฐ”์ด์˜ค(์ฃผ)
Entity Address
๊ฒฝ๊ธฐ๋„ ์„ฑ๋‚จ์‹œ ์ˆ˜์ •๊ตฌ ์ฒญ๊ณ„์‚ฐ๋กœ 734 5์ธต(๊ณ ๋“ฑ๋™, ๋งˆ์ŠคํŠธ๋นŒ๋”ฉ)
Manufacturer
VISIA imaging S.r.l.
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 1194 ํ˜ธ
Important Dates & Status
Item Approval Date
Mar 11, 2021
Business Permit Date
Feb 07, 2006
Expiration Period
2021-03-11 ~ 2026-03-10
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
ZEUS dIFine
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DJ Fang

DJ Fang

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