Blood coagulation time analysis device
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This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In Vitro Reception No. 20-1889. Approved on Aug 07, 2020. Registered by Daekwang Meditech Co., Ltd..
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MFDS Official Data
Class I
Basic Information
Item Serial Number
2020005048
License Number
In Vitro Reception No. 20-1889
์ฒด์ธ์์ 20-1889ํธ
Classification Number
J05010.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Blood coagulation time analysis device
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Official English Name
Coagulation analyzer
Company Information
Entity Address
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Manufacturer
LABiTec - LAbor BioMedical Technologies GmbH
Category
Import business
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Business License Number
์ฒด์ธ ์ 175 ํธ
Important Dates & Status
Item Approval Date
Aug 07, 2020
Business Permit Date
Dec 27, 2004
Expiration Period
2020-10-08 ~ 2030-12-31
For Export
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Model Information
Model Name
DCA-1
