Taiwan FDA registration d9e82311b40191e5322a66d759455d35

Yibi Multifunctional Detection System (Blood Ketones/Uric Acid/Total Cholesterol) (Non-sterilized/Sterilized)

TW: 醫必多功能檢測系統(血酮/尿酸/總膽固醇)(未滅菌/滅菌)
Taiwan flagTaiwan·Risk Class 1·Hsinchu General Factory of Weishi Biotechnology Co., Ltd·Registered Jan 26, 2024 – Jan 26, 2029Active
Registration details
Analysis ID
d9e82311b40191e5322a66d759455d35
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
It is limited to the first-level appraisal scope of the "Ketone (Non-quantitative) Test System (A.1435)", "Uric Acid Test System (A.1775)", "Cholesterol (Total) Test System (A.1175)", and "Manual Instruments for General Surgery (I.4800)" in the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1775 Uric acid testing system;; A.1435 Ketone (non-quantitative) testing system;; A.1175 Cholesterol (Total) Testing System
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Jan 26, 2024
Expiry Date
Jan 26, 2029
About this record

Access comprehensive regulatory information for Yibi Multifunctional Detection System (Blood Ketones/Uric Acid/Total Cholesterol) (Non-sterilized/Sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d9e82311b40191e5322a66d759455d35 and manufactured by Hsinchu General Factory of Weishi Biotechnology Co., Ltd. The authorized representative in Taiwan is Hsinchu General Factory of Weishi Biotechnology Co., Ltd.

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