Taiwan FDA registration b153ac464eadddb3750a3a70f3bc004c

Ambimetric glycated hemoglobin monitoring system

TW: 安必測糖化血色素監測系統

Taiwan·Risk Class 2·Inner Lake Plant of AXA Shengke Co., Ltd·Registered Jul 10, 2019 – Jul 10, 2029Active

Registration details

Analysis ID: b153ac464eadddb3750a3a70f3bc004c

Company information

Manufacturer: Inner Lake Plant of AXA Shengke Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: IXENSOR CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7470 Analysis of glycosylated hemoglobin
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Jul 10, 2019
Expiry Date: Jul 10, 2029

About this record

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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