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HemosIL Liquid Anti-Xa - Taiwan Registration 0aaff72cf3c1815399f45b83e9e488aa

Access comprehensive regulatory information for HemosIL Liquid Anti-Xa in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0aaff72cf3c1815399f45b83e9e488aa and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.

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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0aaff72cf3c1815399f45b83e9e488aa
Registration Details
Taiwan FDA Registration: 0aaff72cf3c1815399f45b83e9e488aa
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Device Details

HemosIL Liquid Anti-Xa
TW: ๅธŒๆ‘ฉ่ฅฟ็ˆพๆถฒๆ…‹ๆŠ—ๆดปๅŒ–็ฌฌๅๅ› ๅญ่ฉฆ้ฉ—็ต„
Risk Class 2
MD

Registration Details

0aaff72cf3c1815399f45b83e9e488aa

Ministry of Health Medical Device Import No. 031764

DHA05603176404

Company Information

United States

Product Details

This product is used by IL agglutination system (ACL TOP Family and ELITE PRO) with HemosIL heparin correction solution (HemosIL Heparin Calibrators) to quantify the activity of traditional heparin (UFH) and low molecular weight heparin (LMWH) in human plasma after citrate treatment. This product is also used to measure the concentration of direct inhibitors of factor Xa (e.g., Rivaroxaban, Apixaban) in human plasma after citrate treatment with HemosIL Rivaroxaban Correction Solution (for Rivaroxaban test) and HemosIL Apixaban Correction Solution (for Apixaban Test) after citrate treatment.

B Hematology and pathology devices

B7525 Heparin analysis

Imported from abroad

Dates and Status

Oct 29, 2018

Oct 29, 2028