Taiwan FDA registration e11fb6575eab456d8f777806dc195205

"Sysmecon" automatic blood coagulation analyzer

TW: “希森美康”全自動血液凝固分析儀
Taiwan flagTaiwan·Risk Class 2·SYSMEX CORPORATION, I-SQUARE·Registered Dec 29, 2021 – Dec 29, 2026Active
Registration details
Analysis ID
e11fb6575eab456d8f777806dc195205
Customs Code
DHA05603492708
Company information
Manufacturer Country
Japan
Authorized Representative
SYSMEX TAIWAN CO., LTD.
Product details
Intended Use
This product is an automated hemagglutination analyzer intended for use by properly trained medical professionals for in vitro diagnostics to help diagnose patients. This product analyzes blood coagulation parameters by coagulation, colorimetry, immunoanalysis, agglutination and chemiluminescence enzyme immunoanalysis.
Product Type (Level 1)
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2)
B.5400 Agglutination apparatus;; A.2160 Individual Photometric Chemistry Analyzer for Clinical Use
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Dec 29, 2021
Expiry Date
Dec 29, 2026
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About this record

Access comprehensive regulatory information for "Sysmecon" automatic blood coagulation analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e11fb6575eab456d8f777806dc195205 and manufactured by SYSMEX CORPORATION, I-SQUARE. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE, SYSMEX CORPORATION; SYSMEX RA CO., LTD., 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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