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"Sysmecon" automatic blood coagulation analyzer - Taiwan Registration e11fb6575eab456d8f777806dc195205

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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e11fb6575eab456d8f777806dc195205
Registration Details
Taiwan FDA Registration: e11fb6575eab456d8f777806dc195205
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Device Details

"Sysmecon" automatic blood coagulation analyzer
TW: โ€œๅธŒๆฃฎ็พŽๅบทโ€ๅ…จ่‡ชๅ‹•่ก€ๆถฒๅ‡ๅ›บๅˆ†ๆžๅ„€
Risk Class 2

Registration Details

e11fb6575eab456d8f777806dc195205

DHA05603492708

Company Information

Product Details

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.

B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology

B.5400 Agglutination apparatus;; A.2160 Individual Photometric Chemistry Analyzer for Clinical Use

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Dec 29, 2021

Dec 29, 2026