Smart Medical Devices

Changzhou Jiangsu, China

Changzhou Hualian Health Dressing Co., Ltd. (hereinafter referred to as "Hualian Health Dressing") is a "national-level professional, refined, special and innovative ‘little giant enterprise’ ", and a high-tech enterprise mainly engaged in the research and development, production and sales of health dressings, sports protection, emergency rescue and other sanitary materials and medical supplies. Its main products cover Class I and Class II medical devices, including medical tapes, bandages, adhesive plasters, wound dressings, sports tapes, first-aid-kits and masks, etc. As of December 31, 2022, Hualian Health Dressing has obtained 156 patents, of which 7 are invention patents. Hualian Health Dressing has established a complete quality control system in terms of quality control,and carries out strict quality control in accordance with the quality standards of the target market. It has passed the internationally accepted quality management system certification for medical device products (ISO 13485:2016), and the CE certification in the EU market, FDA certification in the US market, health certification in the Japanese market, BRC certification in the UK market, etc. Hualian Health Dressing also possess 7 domestic Class II medical device registration certificates, 30 Class I medical device certificates, 5 categories of products have passed EU CE certification, 2 categories of products have obtained US 510(k) product registration, and 31 categories of products have obtained US FDA medical device product registration, the main product production line has obtained the J-GMP certification of Japan and the BRC certification of the United Kingdom, etc., and has obtained "Jiangsu Province Private Technology Enterprise", Jiangsu Province "Industry-Education Integration Pilot Enterprise", Jiangsu Province " Enterprise Technology Center", "Jiangsu Functional Wound Care and Repair Dressing Engineering Technology Research Center", "Jiangsu Medical Device Manufacturing Enterprise Integrity Unit" and many other honors and certifications. Smart Factory - Jiangsu Province specialized new enterprise, Jiangsu Province postdoctoral innovation practice base The company has won the honors of "Four Nebula Platform in Jiangsu Province" and "Changzhou Intelligent Manufacturing Demonstration Workshop" and ranks among the advanced manufacturing industrial clusters in Jiangsu Province. The company has obtained the SGS certification body CE product certification, ISO13485 quality certification, BRC certification, in 2001 in the United States Food and Drug Administration registration. The company is Europe, North and South America, the Middle East, Southeast Asia, Africa, Oceania and other countries recognized manufacturers.