Taiwan FDA registration f5229cede3db0d753819b5ad66a9dd75

Ambiset Multifunctional Detection System (Lipids) (Non-sterilized)

TW: 安必測多功能檢測系統(血脂)(未滅菌)

Taiwan·Risk Class 1·Inner Lake Plant of AXA Shengke Co., Ltd·Registered Dec 04, 2023 – Dec 04, 2028Active

Registration details

Analysis ID: f5229cede3db0d753819b5ad66a9dd75

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)", "Cholesterol (Total) Test System (A.1175)" and "Lipoprotein Test System (A.1475)" 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: Dec 04, 2023
Expiry Date: Dec 04, 2028

About this record

Access comprehensive regulatory information for Ambiset Multifunctional Detection System (Lipids) (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f5229cede3db0d753819b5ad66a9dd75 and manufactured by Inner Lake Plant of AXA Shengke Co., Ltd. The authorized representative in Taiwan is IXENSOR CO., LTD..

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