Taiwan FDA registration 12d0aa03e5086f6669087f71b25b0e2c

Sysmex Automated Immunoassay Analyzer (Unsterilized)

TW: "希森美康" 全自動免疫分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
12d0aa03e5086f6669087f71b25b0e2c
Customs Code
DHA08401568909
Company information
Manufacturer Country
Japan
Authorized Representative
SYSMEX TAIWAN CO., LTD.
Product details
Intended Use
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.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2160 Individual Photometric Chemistry 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 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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