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Blood Transfusion Medical General-purpose Quality Control Substance

์ˆ˜ํ˜ˆ์˜ํ•™๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆ

This Class III 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 water 22-288. Approved on Dec 16, 2022. Registered by Biorad Korea Co., Ltd..

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MFDS Official Data
Class III
Basic Information
Item Serial Number
2022006465
License Number
In vitro water 22-288
์ฒด์™ธ์ˆ˜ํ—ˆ22-288ํ˜ธ
Classification Number
L02060.03(3)
Device Class (Risk Classification)
Class III
Classification Name
Blood Transfusion Medical General-purpose Quality Control Substance
์ˆ˜ํ˜ˆ์˜ํ•™๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆ
Official English Name
General calibrators, controls or standards, class โ…ข, for blood transfusion
Company Information
Entity Name (Company)
Biorad Korea Co., Ltd.
ํ•œ๊ตญ๋ฐ”์ด์˜ค๋ž˜๋“œ(์ฃผ)
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์—ญ์‚ผ๋กœ 114 ,10์ธต(์—ญ์‚ผ๋™,ํ˜„์ฃฝ๋นŒ๋”ฉ)
Manufacturer
Bio-Rad Medical Diagnostics GmbH
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 719 ํ˜ธ
Important Dates & Status
Item Approval Date
Dec 16, 2022
Business Permit Date
May 26, 2005
Expiration Period
2022-12-16 ~ 2027-12-15
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
816030
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