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"Kaijie" Danex Diess Automatic enzyme immunoassay analyzer (unsterilized) - Taiwan Registration 34501b79e73087ad11593aa0681c92a9

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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34501b79e73087ad11593aa0681c92a9
Registration Details
Taiwan FDA Registration: 34501b79e73087ad11593aa0681c92a9
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Device Details

"Kaijie" Danex Diess Automatic enzyme immunoassay analyzer (unsterilized)
TW: "ๅ‡ฑๆฐ" ไธน่€ๅ…‹ๆ–ฏ่ฟชๆ–ฏ ๅ…จ่‡ชๅ‹•้…ต็ด ๅ…็–ซๅˆ†ๆžๅ„€ (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

34501b79e73087ad11593aa0681c92a9

DHA08401823501

Company Information

United States

Product Details

Limited to the classification and grading management measures of medical equipment "Enzyme Analyzer for Clinical Use (A.2500)" first level identification range.

A Clinical chemistry and clinical toxicology

A.2500 Enzyme analyzer for clinical use

Input;; QMS/QSD

Dates and Status

Oct 01, 2021

Oct 31, 2025

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