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"Albergene" Nucleic Acid Amplification Analyzer (Unsterilized) - Taiwan Registration 165ed5b79af781cf3038e9e13ca40d53

Access comprehensive regulatory information for "Albergene" Nucleic Acid Amplification 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 165ed5b79af781cf3038e9e13ca40d53 and manufactured by HIBERGENE DIAGNOSTICS;; OptiGene Limited. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY 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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165ed5b79af781cf3038e9e13ca40d53
Registration Details
Taiwan FDA Registration: 165ed5b79af781cf3038e9e13ca40d53
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Device Details

"Albergene" Nucleic Acid Amplification Analyzer (Unsterilized)
TW: โ€œ่‰พๆŸๅŸบๅ› โ€ๆ ธ้…ธๆ”พๅคงๆ“ดๅขžๅˆ†ๆžๅ„€ (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

165ed5b79af781cf3038e9e13ca40d53

DHA09402097207

Company Information

Ireland;;United Kingdom

Product Details

Limited to the classification and grading management method of medical equipment, the first level identification range of microchemical analyzer (A.2170) used in clinical use.

A Clinical chemistry and clinical toxicology

A.2170 Microchemical analyzer for clinical use

่ผธๅ…ฅ;; QMS/QSD;; ๅง”่จ—่ฃฝ้€ 

Dates and Status

Oct 23, 2019

Oct 23, 2024