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Ambimetric All-in-One Lipid Monitoring System (Unsterilized) - Taiwan Registration f61d97e3b4d6e699addf97db5c741889

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..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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f61d97e3b4d6e699addf97db5c741889
Registration Details
Taiwan FDA Registration: f61d97e3b4d6e699addf97db5c741889
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Device Details

Ambimetric All-in-One Lipid Monitoring System (Unsterilized)
TW: ๅฎ‰ๅฟ…ๆธฌๅคšๅˆไธ€่„‚่ณช็›ฃๆธฌ็ณป็ตฑ(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

f61d97e3b4d6e699addf97db5c741889

Company Information

Taiwan, Province of China

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1475 Lipoprotein Testing System;; A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System

QMS/QSD;; ๅœ‹็”ข

Dates and Status

May 03, 2019

May 03, 2029