Taiwan FDA registration 34501b79e73087ad11593aa0681c92a9

"Kaijie" Danex Diess Automatic enzyme immunoassay analyzer (unsterilized)

TW: "凱杰" 丹耐克斯迪斯 全自動酵素免疫分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·DYNEX TECHNOLOGIES INC.·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
34501b79e73087ad11593aa0681c92a9
Customs Code
DHA08401823501
Company information
Manufacturer Country
United States
Authorized Representative
QIAGEN TAIWAN COMPANY LIMITED
Product details
Intended Use
Limited to the classification and grading management measures of medical equipment "Enzyme Analyzer for Clinical Use (A.2500)" first level identification range.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2500 Enzyme analyzer for clinical use
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2025
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About this record

Access comprehensive regulatory information for "Kaijie" Danex Diess Automatic enzyme immunoassay analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 34501b79e73087ad11593aa0681c92a9 and manufactured by DYNEX TECHNOLOGIES INC.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including DYNEX TECHNOLOGIES INC., and 1 recent registrations in the same category. 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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