On September 19, Gelonhui announced that Anhui Wanyi Science and Technology (688600.SH) has received the Ultrasonic Soft Tissue Surgical Equipment Medical Device Registration Certificate issued by the National Medical Products Administration. For specific details, please refer to the announcement "Anhui Wanyi Science and Technology Co., Ltd.'s voluntary disclosure of obtaining the medical device registration certificate" disclosed on the Shanghai Stock Exchange website on September 7, 2024. The company recently received the "Medical Device Production License" issued by the Anhui Provincial Drug Administration.
This time, the company's acquisition of the "Medical Device Production License" provides qualification guarantee for the future production and sales of products, the company will actively promote the market for minimally invasive surgical instruments and high-value consumables, and organize production in accordance with relevant regulations, standards, and product technical requirements such as the "Regulations for the Supervision and Administration of Medical Devices" and the "Administrative Measures for the Supervision and Management of Medical Device Production," ensuring the quality and production capacity of the company's products to meet market demand. The acquisition of the "Medical Device Production License" this time will not have a significant impact on the company's performance in the short term, and is expected to have a positive impact on the company's future operations.