Thyroid function hormone test reagent
๊ฐ์์ ๊ธฐ๋ฅํธ๋ฅด๋ชฌ๊ฒ์ฌ์์ฝ
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 23-4088. Approved on Feb 15, 2023. Registered by Roche Diagnostics Korea.
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MFDS Official Data
Class II
Basic Information
Item Serial Number
2023000831
License Number
In vitro 23-4088
์ฒด์ธ์์ธ23-4088ํธ
Classification Number
J11060.01(2)
Device Class (Risk Classification)
Class II
Classification Name
Thyroid function hormone test reagent
๊ฐ์์ ๊ธฐ๋ฅํธ๋ฅด๋ชฌ๊ฒ์ฌ์์ฝ
Official English Name
IVD Reagents for thyroid function hormone tests
Company Information
Entity Address
์์ธํน๋ณ์ ๊ฐ๋จ๊ตฌ ํ
ํค๋๋ก108๊ธธ 22 , 4์ธต~8์ธต(๋์น๋, ์๊ฒฝ๋น๋ฉ)
Category
Import business
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Business License Number
์ฒด์ธ ์ 730 ํธ
Important Dates & Status
Item Approval Date
Feb 15, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-02-15 ~ 2028-02-14
For Export
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Model Information
Model Name
09043276190 1 case
09043276190์ธ 1๊ฑด
