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Automatic medical separation method clinical chemistry analysis device

์˜๋ฃŒ์šฉ๋ถ„๋ฆฌ๋ฐฉ์‹์ž„์ƒํ™”ํ•™์ž๋™๋ถ„์„์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. 17-182. Approved on Jan 19, 2017. Registered by Dong Aesti Co., Ltd..

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MFDS Official Data
Class I
Basic Information
Item Serial Number
2017000375
License Number
In Vitro Reception No. 17-182
์ฒด์™ธ์ˆ˜์‹ 17-182ํ˜ธ
Classification Number
J01020.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Automatic medical separation method clinical chemistry analysis device
์˜๋ฃŒ์šฉ๋ถ„๋ฆฌ๋ฐฉ์‹์ž„์ƒํ™”ํ•™์ž๋™๋ถ„์„์žฅ์น˜
Official English Name
Clinical chemistry automated analyser
Company Information
Entity Name (Company)
Dong Aesti Co., Ltd.
๋™์•„์—์Šคํ‹ฐ(์ฃผ)
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๋™๋Œ€๋ฌธ๊ตฌ ์ฒœํ˜ธ๋Œ€๋กœ 64 (์šฉ๋‘๋™)
Manufacturer
Thermo Fisher Scientific Oy
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 561 ํ˜ธ
Important Dates & Status
Item Approval Date
Jan 19, 2017
Business Permit Date
May 16, 2005
Expiration Period
2020-10-08 ~ 2030-02-28
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
Indiko
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DJ Fang

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