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Ambimetric glycated hemoglobin monitoring system - Taiwan Registration b153ac464eadddb3750a3a70f3bc004c

Access comprehensive regulatory information for Ambimetric glycated hemoglobin 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 b153ac464eadddb3750a3a70f3bc004c and manufactured by Inner Lake Plant of AXA Shengke Co., Ltd. The authorized representative in Taiwan is IXENSOR CO., LTD..

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b153ac464eadddb3750a3a70f3bc004c
Registration Details
Taiwan FDA Registration: b153ac464eadddb3750a3a70f3bc004c
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Device Details

Ambimetric glycated hemoglobin monitoring system
TW: ๅฎ‰ๅฟ…ๆธฌ็ณ–ๅŒ–่ก€่‰ฒ็ด ็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

b153ac464eadddb3750a3a70f3bc004c

Company Information

Taiwan, Province of China

Product Details

This product is intended for in vitro diagnostics for the quantitative measurement of glycated hemoglobin (% HbA1c) in venous whole blood or fingertip blood samples. This product is intended for use by professionals only.

B Hematology, pathology, and genetics

B.7470 Analysis of glycosylated hemoglobin

QMS/QSD;; ๅœ‹็”ข

Dates and Status

Jul 10, 2019

Jul 10, 2029