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Yibi Multifunctional Detection System (Blood Ketones/Uric Acid/Total Cholesterol) (Non-sterilized/Sterilized) - Taiwan Registration d9e82311b40191e5322a66d759455d35

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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d9e82311b40191e5322a66d759455d35
Registration Details
Taiwan FDA Registration: d9e82311b40191e5322a66d759455d35
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Device Details

Yibi Multifunctional Detection System (Blood Ketones/Uric Acid/Total Cholesterol) (Non-sterilized/Sterilized)
TW: ้†ซๅฟ…ๅคšๅŠŸ่ƒฝๆชขๆธฌ็ณป็ตฑ(่ก€้…ฎ/ๅฐฟ้…ธ/็ธฝ่†ฝๅ›บ้†‡)(ๆœชๆป…่Œ/ๆป…่Œ)
Risk Class 1

Registration Details

d9e82311b40191e5322a66d759455d35

Company Information

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1775 Uric acid testing system;; A.1435 Ketone (non-quantitative) testing system;; A.1175 Cholesterol (Total) Testing System

QMS/QSD;; ๅœ‹็”ข

Dates and Status

Jan 26, 2024

Jan 26, 2029