South Korea MFDS registration In Vitro Reception No. 20-1889

Blood coagulation time analysis device

KO: 혈액응고시간분석장치
South Korea flagSouth Korea·Class I·Daekwang Meditech Co., Ltd.·Approved Aug 07, 2020
Basic information
Item Serial Number
2020005048
License Number
In Vitro Reception No. 20-1889
체외수신20-1889호
Classification Number
J05010.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Blood coagulation time analysis device
혈액응고시간분석장치
Official English Name
Coagulation analyzer
Company information
Entity Name (Company)
Daekwang Meditech Co., Ltd.
(주)대광메디텍
Entity Address
서울특별시 동작구 동작대로35길 5
Manufacturer
LABiTec - LAbor BioMedical Technologies GmbH
Category
Import business
수입업
Business License Number
체외 제 175 호
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
아니오
Model information
Model Name
DCA-1
About this record

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Reception No. 20-1889. Approved on Aug 07, 2020. Registered by Daekwang Meditech Co., Ltd..

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