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Sysmex Automated Immunoassay Analyzer (Unsterilized) - Taiwan Registration 12d0aa03e5086f6669087f71b25b0e2c

Access comprehensive regulatory information for Sysmex Automated 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 12d0aa03e5086f6669087f71b25b0e2c and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including SYSMEX CORPORATION, I-SQUARE, SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE, and 5 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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12d0aa03e5086f6669087f71b25b0e2c
Registration Details
Taiwan FDA Registration: 12d0aa03e5086f6669087f71b25b0e2c
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Device Details

Sysmex Automated Immunoassay Analyzer (Unsterilized)
TW: "ๅธŒๆฃฎ็พŽๅบท" ๅ…จ่‡ชๅ‹•ๅ…็–ซๅˆ†ๆžๅ„€ (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

12d0aa03e5086f6669087f71b25b0e2c

DHA08401568909

Company Information

Product Details

Limited to the first level identification range of the "Individual Photometric Chemistry Analyzer for Clinical Use (A.2160)" of the Measures for the Classification and Grading of Medical Devices.

A Clinical chemistry and clinical toxicology

A.2160 Individual Photometric Chemistry Analyzer for Clinical Use

Input;; QMS/QSD

Dates and Status

Oct 01, 2021

Oct 31, 2025

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