Taiwan FDA registration d80533a7c2ed89e16f2a025920996930

Corno blood glucose/cholesterol monitoring system

TW: 可諾 血糖/膽固醇 監測系統
Taiwan flagTaiwan·Risk Class 2·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Aug 28, 2017 – Sep 15, 2020Cancelled
Registration details
Analysis ID
d80533a7c2ed89e16f2a025920996930
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
KERNEL INT'L CORP.
Product details
Intended Use
This product is intended for in vitro testing only to measure blood glucose and cholesterol levels by measuring fresh fingertip microvascular whole blood. This product is intended for use by self-testing and healthcare professionals, but is not intended for testing in newborns.
Product Type (Level 1)
A Clinical Chemistry and Clinical Toxicology;; I General, Plastic Surgery and Dermatology
Product Type (Level 2)
I.4800 Manual instruments for general surgery; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System
Import Information
Contract manufacturing;; Domestic
Dates and status
Registration Date
Aug 28, 2017
Expiry Date
Sep 15, 2020
Cancellation Date
Oct 19, 2020
Cancellation information
Status
Logged out
Reason
屆期未申請展延
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About this record

Access comprehensive regulatory information for Corno blood glucose/cholesterol monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d80533a7c2ed89e16f2a025920996930 and manufactured by Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is KERNEL INT'L CORP..

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