Copyright © 2018 Nanjing Shuangwei Biotechnology Co., Ltd. Jiangsu ICP No.05023847号 

Internet drug information service qualification certificate: (Su) - non operational -2013-0042



Development History

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In December 2015, it obtained category II medical device registration certificate of disposable prostate expansion catheters.
On December 8, 2015, Jiangsu Institute of Composite Materials Biocomposite Professional Committee was formally established in Nanjing Shuangwei Biotech, and Shuangwei Biotech served as a chairman unit.
In August 2015, its registered capital was increased from 21.60 million yuan to 50 million yuan.
In June 2015, it obtained category III medical device registration certificate of plasma virus inactivation filter.
In June 2015, it obtained the category III medical device registration certificate of negative pressure wound drainage set.
In March 2015, the paper Transurethral Split of the Prostate with a Columnar Balloon Catheter was published in the renown journal New York Laparoscopic Urology.
On May 28, 2014, "Nanjing Blood Purification Medical Equipment Products Engineering Technology Research Center" was formally established in the company.
In 2013, the company became the first batch of units passing the GMP certification organized by China Food and Drug Administration.
In 2012, the soft-shell white blood cell filters were launched into the international markets.
In March 2010, it invested 10 million yuan to build the production line of annual production of 1 million sets of high-performance white blood cell filters.
In 2008, the Company’s independently researched and developed plasma virus inactivation filters and inactivation cabinets entered into clinical validation.
From 2008 till now, the company was rated as “Following Contract and Observing Credit” enterprise by Nanjing Municipal People's Government.
In 2007, it published paper about degreasing filter on international famous journal Therapeutic monotherapy and dialysis.
In 2006, it got the drug production license and drug registration approval, and passed the on-site audit of GMP certification.
In 2005, it was rated as outstanding, credible medical device enterprise, and from 2007 to 2009m 2010-2012 and 2013 to 2015, it has been rated “outstanding, credible medical device enterprise in Jiangsu Province” for five consecutive sessions.
In 2005, Shuangwei WBC filter transfusion sets were listed in the export list of China's high-tech products.
In 2004, it established a WBC-removal blood bag production plant in accordance with GMP requirements.
In 2004, the project “Glass micro-fiber filter leukocyte transfusion technology and industrialization" won the first prize of Science and Technology Progress Award of China Building Materials Association and China Silicate Society.
In 2004, it served as a chairman unit of Nanjing Medical Devices Association .
In 2004, it was rated as ““Following Contract and Observing Credit Unit” by Industrial and Commercial Bureau of High - tech Zone.
In 2003, it was granted the self-operation import and export qualification, and the first batch of WBC filter transfusion sets were exported.
In 2002, it passed the EU ISO9001 / ISO13485 (CE) quality system certification.
In 2001 and 2002, it was rated as high-tech enterprise of Nanjing City, Jiangsu Province, and till now, it is still a high-tech enterprise of Jiangsu Province.
In February 2001, Nanjing Shuangwei Biotechnology Co., Ltd. was formally established.
In 1999, the company worked with Nanjing Red Cross Blood Center to research and develop the BWC-removal platelet type filters, which filled the gap in china; in the same year, main researchers published papers in internationally famous journal VOX SANGUINIS, and the product innovation technologies were highly recognized in the international blood transfusion field.
In 1997, it was the first domestic company to obtain the WBC filter registration certificate, filling the gap in Chinese markets.
In December 1997, the disposable WBC-filter transfusion apparatus products were rated as “national key new products”.
In 1996, the products were used in clinical trials.
In 1994, WBC-filter transfusion apparatus was awarded the national invention patent (Patent No. 94111296.9).
In August 1993, Nanjing Shuangwei Industry Company signed a cooperation agreement with Nanjing Red Cross Blood Center, to jointly develop and develop RBC type WBC-filter transfusion apparatus.