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Becoming a trustworthy manufacturer and service provider of medical equipment

Nanjing Sunway Biomedical Technology Co., Ltd.


Nanjing Shuangwei Biomedical Technology Co., Ltd. (hereinafter referred to as Shuangwei Biology) is an innovative medical device enterprise, founded in 2001, with the two main businesses of safe blood transfusion and wound treatment as the core, supported by the three major platforms of new materials, Shuangwei Medical and sterilization services, focusing on the research and development, production, sales and service of new disposable medical consumables.
Shuangwei Biology is now a holding subsidiary of Nanjing Tongtian Technology Co., Ltd. Nanjing Tongtian Technology Industrial Co., Ltd. was established in September 2000, is a non-listed public company regulated by the CSRC. At present, the company's business to capital operation and holding management-oriented, direct holding, participation in six subsidiaries. The company's products include: medical equipment, non-communication optical fiber, building insulation materials, glass fiber reinforced resin grinding wheel and fund products.

 

Research and development of new high-tech medical devices
In addition to independent research and development investment, Shuangwei Biology fully introduces and relies on external scientific research forces. The company has established extensive cooperative relations with Jiangsu Blood Center, Nanjing Red Cross Blood Center, Institute of Blood Transfusion of Chinese Academy of Medical Sciences, Suzhou Institute of Biomedical Engineering and Technology of Chinese Academy of Sciences, Eastern Theater General Hospital and other domestic universities and medical institutions, as well as universities such as Nanjing Normal University, Nanjing Institute of Technology and China Southern Airlines, specializing in the research and development of new high-tech medical devices.

 

Give full play to the expertise to provide technical support for member units
In recent years, Shuangwei Biology has given full play to its role as a bridge to assist the association in building a platform for communication and promoting the development of the industry. The company led the formation of the Jiangsu Province Composite Materials Bio-based Professional Committee and served as the chairman of the unit, in addition, Shuangwei Biology is also a member of the China Blood Transfusion Equipment Committee, a member of the China Medical Device Industry Association, a member of the Medical Polymer Products Branch of the China Medical Device Industry Association, a member of the National Medical Infusion Device Standardization Technical Committee, and a member of the Jiangsu Blood Transfusion Association., Secretary-General of Nanjing Medical Device Association, Standing Committee of Nanjing Jiangbei New District Federation of Industry and Commerce, and Director of Nanjing Industrial Internet Industry Alliance, provide technical support to members.

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HISTORY

SINCE 2001

Development Process

Nanjing Shuangwei Biotechnology Co., Ltd. was formally established.

2001

2001

Was rated as high-tech enterprises, through the ISO9001/ISO13485 quality system certification, CE certificate.

2002

2002

Self import and export qualification. The first batch of "disposable white blood cell filter blood transfusion equipment" export.

2003

2003

Glass microfiber filter leukocyte transfusion device technology and industrialization, the project won the first prize of China Building Materials Association and China Silicate Society for scientific and technological progress.

2004

2004

"Disposable white blood cell filter blood transfusion equipment" into China's high-tech products import list.

2005

2005

The company's independent research and development of "disposable plasma virus inactivated blood transfusion equipment" into clinical verification.

2008

2008

Investment of 10 million billion yuan to establish an annual output of 1 million sets of high-performance white blood cell filter production line.

2010

2010

Disposable leukocyte filter blood transfusion equipment (soft shell) put on the international market-whole blood type soft shell filter.

2012

2012

"Nanjing blood purification medical products engineering technology center" was formally established in the company.

2014

2014

Wound closed negative pressure drainage suit, disposable plasma virus inactivated blood transfusion equipment to obtain medical device class III registration certificate, disposable prostate dilation catheter to obtain medical device class II registration certificate.

2015

2015

Approved to establish the 'Jiangsu Province Graduate Workstation'

2016

2016

Obtained intellectual property management system certification.

2018

2018

Medical health innovation project "new blood pathogen inactivation project" results settled in Jinling.

2019

2019

Settled in the national Jiangbei New Area Biopharmaceutical Valley BPV.

2020

2020

THREE MAJOR PLATFORMS

Based on the support of its two main businesses, Shuangwei Biology actively develops the medical device industry chain and has established three platforms: sterilization service platform, medical device agency platform, and new material research and development manufacturing platform. These platforms complement each other and build a comprehensive and integrated service ecosystem, enabling us to provide comprehensive support for the medical industry from source material production to terminal services, and continuously promote the progress and development of medical technology.

Sterilization Service Platform

As one of the few enterprises with external sterilization qualifications, Shuangwei Biology has invested 30 million yuan to focus on building explosion-proof workshops and environmentally friendly emissions, ensuring safe production and green development. At present, we have a 100m ³ advanced EO sterilization cabinet and a 20m ³ steam sterilization cabinet, which not only meet the sterilization requirements of our company's products, but also actively serve society. In this service, we have a professional team of engineers and a management technical team that communicate well with customers for various materials and complex structures. We offer flexible service methods and one-on-one communication, providing customers with one-stop EO sterilization services from sterilization consultation, sterilization confirmation, daily sterilization, sterilization testing forced analysis verification, and daily forced analysis.

New material R & D and manufacturing platform

Shuangwei New Materials Industrial Co., Ltd. takes "customer trust and satisfaction" as the primary goal of company management, constantly gives full play to the advantages of technology and talents, devotes itself to the research and development and application of new materials and new technologies, and makes important contributions to social development.

Medical Device Agent Platform

Nanjing shuangwei medical supplies limited company mainly engaged in disposable sterile medical equipment, equipment and other products sales.

HONOR

Shuangwei Biology Company continuously invests in research and development, committed to technological innovation in the field of medical devices. It has obtained more than 80 patents and 1 international patent, and has made significant breakthroughs in product design, manufacturing processes, and functionality. The company has obtained multiple medical device registration certificates and certifications, including 11 domestic Class II and Class III medical device registration certificates, 6 Class I certificates, a medical device production license, and a medical device business license. This reflects the high importance that Shuangwei Biology attaches to product quality and ensures product safety and reliability.
Obtaining the MDR CE certificate for white blood cell filters enables Shuangwei Biology products to enter international markets such as Europe, further expanding the company's business scope and enhancing international competitiveness. At the same time, the company has established a comprehensive quality management system through ISO 13485 and MDSAP medical device quality management system certification, ensuring that products comply with regulatory requirements and meet customer needs. The company has been awarded the title of National Specialized and Innovative "Little Giant" enterprise, demonstrating the leading position and industry influence of Shuangwei Biology in the field of medical devices.

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Medals

We have established extensive cooperative relationships with major universities and research institutes, successfully built an integrated platform for research and development of medical products, and won multiple technical awards at the municipal and provincial levels in the professional field. We have also passed ISO 13485 and MDSAP medical device quality management system certifications, and have been awarded the title of National Specialized and Innovative "Little Giant" Enterprise.

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Certificate

The company has obtained multiple medical device registration certificates and certifications, including 11 domestic Class II and Class III medical device registration certificates, 6 Class I certificates, a medical device production license, and a medical device business license.

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Invention patent

We have obtained over 80 patents in the field of safe blood transfusion and wound treatment, including one international patent. Our company specializes in the research and development of new high-tech medical devices.

CULTURE


Becoming a trustworthy manufacturer and service provider of medical equipment

Mission: To create "high-quality, safe and advanced" medical equipment as its own responsibility, committed to the continuous development of human health, and make greater contributions to society.

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Employee activities

Rich and colorful staff activities

Learning platform

A learning platform for communication