Heart disease marker test reagent
์ฌ์งํํ์ง์๊ฒ์ฌ์์ฝ
This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In Vitro No. 22-664. Approved on Oct 04, 2022. Registered by Ohsang Healthcare Co., Ltd..
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MFDS Official Data
Class III
Basic Information
Item Serial Number
2022005016
License Number
In Vitro No. 22-664
์ฒด์ธ์ ํ22-664ํธ
Classification Number
K02030.01(3)
Device Class (Risk Classification)
Class III
Classification Name
Heart disease marker test reagent
์ฌ์งํํ์ง์๊ฒ์ฌ์์ฝ
Official English Name
IVD reagents for cardiac marker
Company Information
Entity Address
๊ฒฝ๊ธฐ๋ ์์์ ๋์๊ตฌ ์์์ฒ๋๋ก 132 (ํธ๊ณ๋)
Category
Manufacturing
์ ์กฐ์
Business License Number
์ฒด์ธ ์ 652 ํธ
Important Dates & Status
Item Approval Date
Oct 04, 2022
Business Permit Date
Nov 24, 1997
For Export
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Model Information
Model Name
IIM-0001CK
