Company Introduction
Hangzhou Singclean Medical Products Co., Ltd., established in March 2002 with registered capital of 80, 000, 000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials.With highly-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that conform to the laws and regulations of National Medical Products Administration (NMPA) and EU MDR.
Cooperation
The company set up a joint research center with Zhejiang University of Science and Technology, and has well established R&D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology, developing four series of new products with proprietary intellectual property rights, and with a variety of high-tech products to be developed cooperatively.The company also built an R & D platform for medical biomaterials that keeps up with the international level, and made major breakthrough in many key technologies such as those for stopping bleeding, anti-adhesion, and tissue engineering basic materials, with more than 55 patents obtained and a number of products applying for the patents.
Our manufacturing
The company′s plant in Xiasha covers the construction area of 174014.83 m²And producing tract of 13, 200 m²Including cleanrooms of 2, 300 m²In which cleanroom of Class C covers 2, 000 m²And that of Class B covers 300 m²With over 60 m²Of which follows into Class A.A new cleanroom up to GMP standard was set up in this plant, and the Pharmaceutical Production License was obtained in 2012.It will produce all kinds of medical equipment and medical 10 million sets, production value 2 billion, In addition, the plant has introduced more production facilities such as the Invoa filling machine from Germany, the sterilizer from GETINGE, the semi-automatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and 1T / h of pure steam generator.
Quality system
Respect for life strict quality control
The company has set up a documentation-based GB/T19001-2008, YY/T0287-2003, Good manufacturing Practice for medical devices, Good manufacturing practice for In vitro diagnostic reagents, good manufacturing practice of drug, 2010, medical device directive (MDD93/42/EEC ), according to quality objectives, auit resullt, data analysis, corrective and preventive actions and management review, in order to maitain the continued suitability and effectivenss of the quality managenment system.
Technological Innovation
Cohesion of technological strength improving core competitiveness
The company has been always laid stress on product rsearch and development, investing annually 10% of the sales to comstruction of R&D center, new product development and introduction of advance equipments.The R&D center is equipped with cleanroom in Class 10000(including Class 100) of more than 200m², and it has acquired a number of patent technologies.
Product center
Committing herself to develop new types of composite and smart biomaterials, the company majors in producing biodegradable bio-materials and their derivatives, and has at present products of 8 series (chitosan, medical sodium hyaluronate gels, cross-linked hyaluronic acidsodium gels, microporous polysaccharide, oxidized regenerated cellulose, basic materials of tissue engineering, in vitro diagnostic reagents), 50 varieties of cosmetics are being exported to more than 120 countries around the world, such as:Italy, Russia, Turkey, France, Brazil, Chile, Australia, and Canada.Until now, Singclean has got 30+ CE certificates, 16 medical device registration certificates and 46 patent certificates.At Singclean, all their 600 employees are working with the best and committed to excellence.
Hangzhou Singclean Medical Products Co., Ltd., established in March 2002 with registered capital of 80, 000, 000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials.With highly-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that conform to the laws and regulations of National Medical Products Administration (NMPA) and EU MDR.
Cooperation
The company set up a joint research center with Zhejiang University of Science and Technology, and has well established R&D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology, developing four series of new products with proprietary intellectual property rights, and with a variety of high-tech products to be developed cooperatively.The company also built an R & D platform for medical biomaterials that keeps up with the international level, and made major breakthrough in many key technologies such as those for stopping bleeding, anti-adhesion, and tissue engineering basic materials, with more than 55 patents obtained and a number of products applying for the patents.
Our manufacturing
The company′s plant in Xiasha covers the construction area of 174014.83 m²And producing tract of 13, 200 m²Including cleanrooms of 2, 300 m²In which cleanroom of Class C covers 2, 000 m²And that of Class B covers 300 m²With over 60 m²Of which follows into Class A.A new cleanroom up to GMP standard was set up in this plant, and the Pharmaceutical Production License was obtained in 2012.It will produce all kinds of medical equipment and medical 10 million sets, production value 2 billion, In addition, the plant has introduced more production facilities such as the Invoa filling machine from Germany, the sterilizer from GETINGE, the semi-automatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and 1T / h of pure steam generator.
Quality system
Respect for life strict quality control
The company has set up a documentation-based GB/T19001-2008, YY/T0287-2003, Good manufacturing Practice for medical devices, Good manufacturing practice for In vitro diagnostic reagents, good manufacturing practice of drug, 2010, medical device directive (MDD93/42/EEC ), according to quality objectives, auit resullt, data analysis, corrective and preventive actions and management review, in order to maitain the continued suitability and effectivenss of the quality managenment system.
Technological Innovation
Cohesion of technological strength improving core competitiveness
The company has been always laid stress on product rsearch and development, investing annually 10% of the sales to comstruction of R&D center, new product development and introduction of advance equipments.The R&D center is equipped with cleanroom in Class 10000(including Class 100) of more than 200m², and it has acquired a number of patent technologies.
Product center
Committing herself to develop new types of composite and smart biomaterials, the company majors in producing biodegradable bio-materials and their derivatives, and has at present products of 8 series (chitosan, medical sodium hyaluronate gels, cross-linked hyaluronic acidsodium gels, microporous polysaccharide, oxidized regenerated cellulose, basic materials of tissue engineering, in vitro diagnostic reagents), 50 varieties of cosmetics are being exported to more than 120 countries around the world, such as:Italy, Russia, Turkey, France, Brazil, Chile, Australia, and Canada.Until now, Singclean has got 30+ CE certificates, 16 medical device registration certificates and 46 patent certificates.At Singclean, all their 600 employees are working with the best and committed to excellence.
