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About Us

Assure Tech

National High-tech Enterprise

Assure Tech.(Hangzhou) Co., LTD.

Assure Tech

National High-tech Enterprise

Assure Tech.(Hangzhou) Co., LTD.

Assure Tech (Hangzhou) Co., Ltd was established by senior experts of in-vitro diagnostics industry in 2008. As a high-tech biotechnology company, Assure Tech is specialized in research & development, production, sell of diagnostic reagents, POCT and biological materials.

At present, the company has 6,000 square meters of R&D and manufacture base which contains the advanced level of colloidal gold diagnostic reagents production lines with annual production capacity of hundred millions of devices。

Currently, Assure R&D team has more than 100 staff who builds an extensive cooperation with the advanced domestic and foreign research institutions. And in domestic, Assure tech includes an advanced level in the rapid diagnostic reagents area, rapid molecular diagnostic area, the development and preparation of antibody, small molecular antigen synthesis and genetic engineering. What’s more, Assure Tech is committed to R&D in vitro diagnostic reagents area and related products: colloidal gold rapid detection reagents, Quantitative determination of chemilumineseent immunoassay reagent and bioactive materials. More than 100 products in 8 series are developed successfully which contain the following tests: pregnancy test, DOA test, infectious disease test, tumor markers test, cardiac markers test, food safety test, biochemical reagent series test, integration of instruments and reagents.

The Assure Tech products are sold to more than 100 countries and regions, such as Europe, Asia, Africa, Oceania and so on。 Especially the drug detection reagent which has won a wide praise and owned more than 60% market share in some European countries。

Development History

Assure Tech

National High-tech Enterprise

  • 2019
    In September 2019, through various inspection indicators, obtained the factory expansion license and production license, and completed the great leap in the development of anxu.
  • 2018
    In July, MDSAP approved the extension to Brazil.
    In July, it passed the EN ISO 13485:2016 system certification.
  • 2017
    In 2017, it won the honor of "quality integrity" enterprise, completing the great leap in the quality development of anxu.
    In March, I passed the on-site system audit of MDSAP.
  • 2016
    In 2016, zero defects passed the TUV flight inspection.
  • 2015
    In May, it passed iso13485:2012 medical device production quality management system certification, and completed the great leap of quality development of Assure Tech.
  • 2014
    In November, we passed the FDA quality system assessment in the United States and completed the great leap of quality development of Assure Tech.
    In November, we passed the CMDCAS quality system assessment in Canadian and completed the great leap of quality development of Assure Tech.
  • 2011
    Assure Tech Through various inspection indicators, it was awarded the license of medical device manufacturer.

Honorary Qualification

Assure Tech

National High-tech Enterprise

WeChat

WeChat QR Code

Add:Building 4,No. 1418-50,Moganshan Road,Hangzhou ,China,310011

Tel:(86)571-81022698

Fax:(86)571-88865920

E-mail:contact@hsalcp.com

Website:www.hsalcp.com / 

Copyright © 2020 Assure Tech.(Hangzhou) Co., LTD. All Rights Reserved.        
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