Core Viewpoint - Tianyi Medical (301097.SZ) has received a Medical Device Registration Certificate from the National Medical Products Administration for its subsidiary Ningbo Tianyi Pharmaceutical Technology Co., Ltd, enhancing its product portfolio and competitive edge in the market [1]. Group 1: Product Registration Details - The registered product is a blood dialysis concentrate, classified as a Class III medical device, with a registration number of Guo Xie Zhu Zheng 2025310230, valid from November 13, 2025, to November 12, 2030 [2]. - The blood dialysis concentrate consists of two components: A concentrate (A liquid) and a connected dry powder (B powder), designed to meet the personalized treatment needs of patients with acute and chronic renal failure [2]. - A liquid is composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, acetic acid, and dialysis water, while B powder contains sodium bicarbonate, utilizing acetic acid as a buffer in a medium calcium formulation [2]. Group 2: Strategic Implications - The acquisition of the medical device registration certificate extends the company's product chain and enriches its product categories, which is beneficial for enhancing the company's overall competitiveness in the healthcare market [2].
天益医疗(301097.SZ)：新产品血液透析浓缩物取得产品注册证书