Taiwan FDA registration f61d97e3b4d6e699addf97db5c741889

Ambimetric All-in-One Lipid Monitoring System (Unsterilized)

TW: 安必測多合一脂質監測系統(未滅菌)

Taiwan·Risk Class 1·Inner Lake Plant of AXA Shengke Co., Ltd·Registered May 03, 2019 – May 03, 2029Active

Registration details

Analysis ID: f61d97e3b4d6e699addf97db5c741889

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: It is limited to the first level of identification of the "Triglyceride Test System (A.1705)", "Lipoprotein Test System (A.1475)" and "Cholesterol (Total) Test System (A.1175)" of the Medical Device Classification and Grading Management Measures.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1475 Lipoprotein Testing System;; A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: May 03, 2019
Expiry Date: May 03, 2029

About this record

Access comprehensive regulatory information for Ambimetric All-in-One Lipid Monitoring System (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f61d97e3b4d6e699addf97db5c741889 and manufactured by Inner Lake Plant of AXA Shengke Co., Ltd. The authorized representative in Taiwan is IXENSOR CO., LTD..

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