Company Introduction
Hangzhou Singclean Medical Products Co., Ltd., established in March 2003 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 well-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 confirm to the laws and regulations of the State Food and Drug Administration (SFDA) and EU MDD.
The company’s plant in Xiasha covers an area of 13,000 m² with the construction area of 17,000 m² and producing tract of 13,200 m² including cleanrooms of 2,300 m² in which cleanroom of Class C covers 2,000 m² and that of Class B covers 300 m² with over 60 m² of 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 semiautomatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and1T / h of pure steam generator.
Brand name: Singclean, Singfiller, Quickclean,Singjoint
Qualification &honoors
The company passed the ISO9001 quality management system certification and ISO13485 medical devices quality management system certification in 2007, and obtained in 2008 the Innovation Fund Certificate certified by the Ministry of Science and Technology with her MPH hemostatic microspheres project. The company obtained the certification of high and new technology enterprise of Hangzhou in 2007, of Zhejiang Province in 2008, of China in 2010, and her medical sodium hyaluronatethe gels passed the CE certification in 2011.
