山东新华医疗器械股份有限公司关于子公司产品获得二类医疗器械注册证的公告

Core Viewpoint - The announcement highlights that Xinhua Medical's subsidiary has received a Class II medical device registration certificate for a new rehabilitation product, which is expected to enhance the company's competitive edge in the rehabilitation market [1][5]. Group 1: Medical Device Registration Details - The product is named "Four-Limb Linked Rehabilitation Training Device" and has been registered under the certificate number 陕械注准20262190001 [1][2]. - The registration was granted by the Shaanxi Provincial Drug Administration, with the approval date being January 23, 2026, and it is valid until January 22, 2031 [3]. - The device is designed to assist in improving limb strength and coordination, as well as enhancing joint mobility for patients with neurological or motor system injuries [2][4]. Group 2: Product Features and Applications - The device features a mechanical structure that allows for synchronized movement of limbs, aiding in rehabilitation for conditions such as hemiplegia and joint injuries [4]. - It is intended for use in stroke rehabilitation, improving blood circulation and metabolism in muscles, bones, and ligaments, while also enhancing strength, endurance, and balance [4]. Group 3: Impact on Company Performance - The approval of the Four-Limb Linked Rehabilitation Training Device is expected to meet the rehabilitation needs of patients with neurological or motor system injuries, thereby enriching Xinhua Medical's product line and enhancing its core competitiveness [5].