Founded in 1991, KLFmed was born with the vision of becoming a trusted partner in the development of Single Use Medical Devices. KLFmed focuses on kinds of medical devices for single use including Burette Infusion Sets, Safety Infusion Sets, Infusion Sets for intensive care etc.
In order to offer countries high-quality product, Klfmed, according to ISO13485, has established safe and effective quality management system. The year of 2003 has seen the ISO 13485 Certificate and CE Certificate by TUV SUD. In 2016, we passed FDA’s on-site audit and domestic GMP.
KLFmed has a group of three hundred and consists of engineers, designers, specialists in quality and inspection as well as trained production workers. Equipped with multiple air handling units at present, KLFmed has an floor space of about 37,000m2. Furthermore, KLFmed owns 9,000m2 of 100,000-Class production clean room, including 10,000-Class inspection clean room and two EO-sterilized lines integrated with preconditioning, sterilization and aeration.
With more than 100 million sterile single-use medical devices produced and delivered around the globe each year, KLFmed is a specialist in Infusion therapy devices and our engagement is to provide high-quality products while helping customers improve their cost efficiency.