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Hybiome Profile

Our Mission

Research & Development

Quality Management

Certificate

Employee

Hybiome Profile

 Suzhou Hybiome Biomedical Engineering Co. Ltd was co-founded by Suzhou Institute of Biomedical Engineering and Technology, Changchun Institute of Optics and Fine Mechanics and Physics, and Mr. Jianhua Dong in 2009. Suzhou Hybiome is a high-tech enterprise focused on R&D, production, and distribution of in vitro diagnostic products. Our main products include automated chemiluminescence immunoassay (CLIA) analyzers and reagents. We have also been the first Chinese CFDA approved provider of automatic blood grouping analyzers for microcolumn gel card; a blood grouping technology.

We are actively promoting exchanges and cooperation with domestic and overseas scientific institutes, and are dedicated to provide the market with High-quality IVD products for clinical diagnosis. We believe that Hybiome will become the domestic leading enterprise in the IVD industry within a few years.

While meeting the needs of the domestic market for clinical diagnostic, we have also been actively participating in the certification of International quality systems. Promoting Hybiome products into international markets furthers the internationalization of Hybiome.

Our Mission

Devoted to human health and happiness,

Supply accurate & high efficient IVD systems,

be a reliable medical device supplier

Research & Development

From 2009 to 2012, Hybiome, together with the Suzhou Institute of Biomedical Engineering and Technology, Changchun Institute of Optics and Fine Mechanics and Physics, jointly developed the leading automatic chemiluminescence immunoassay ananlyzer AE-180 and the first domestic automated blood grouping analyzer SA-120 with microcolumn gel card blood grouping technology.

From 2013 to 2015, Hybiome and a Japanese professional research institute jointly developed the automatic chemiluminescent immunoassay analyzer AE-240, which fulfills all requirements of the advanced international standard for AE based chemiluminescence.

From 2016 to 2018, based on the design experience of AE-180 and AE-240, Hybiome independently developed the automatic chemiluminescence immunoassay analyzer AE-120.

AE-240, AE-180, and AE-120 have been obtained class II medical device certificates by CFDA and have been successfully put into production and sales.

Besides, Hybiome independently developed Chemiluminescence reagent kits and has  obtained more than 85 certificates approved by CFDA. And we are developing more exciting new products every year.

Suzhou Hybiome has nearly 100 R&D engineers, and more than 100 patent authorizations granted, of which invention patents account for more than 37%. In the future, Hybiome will continue to increase research and development investment, adhere to technological innovation, to maintain product technology and a industry competitive advantage in this field.

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Quality Management

Quality Policy: Quality is the life of an enterprise, and integrity is the cornerstone of enterprise development.

Our Goal:

1. Business operation should be legal and standard.

2. Covered medical devices are of good quality, safe and effective.

3. The company runs effectively and continuously to improve the company's quality management system;

4. We are permanently improving quality, reputation and economic benefits of the company.

5. We fully understand and strive to meet the needs of our customers and the market.

Certificates
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Suzhou Hybiome Biomedical Engineering Co. Ltd

Address: Block 4, No.8, Jinfeng Road, Suzhou, China

Tel: +86-512-66895311

Fax: +86-512-66897061

Email: hybiome@hybiome.com

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