海利生物(603718.SH):骨修复材料三类医疗器械注册申请获得受理

Core Viewpoint - Haili Biological (603718.SH) announced that its subsidiary, Shaanxi Ruisheng Biotechnology Co., Ltd., has received a medical device registration application acceptance notice from the National Medical Products Administration for a bone repair material [1] Company Summary - The product, classified as a Class III medical device, falls under the category of oral medical devices, specifically "17-08 Oral Implant and Tissue Reconstruction Materials" and "17-08-06 Bone Filling and Repair Materials" [1] - The product classification code is 17-08-06, indicating its specific use in the dental field [1] - Once approved for market launch, this product will enhance Ruisheng Biological's product line in the field of oral bone defect repair [1] Industry Summary - The approval of this bone repair material aligns with the growing demand for advanced medical devices in the dental sector, particularly for bone repair solutions [1] - The classification as a Class III medical device suggests a significant level of regulatory scrutiny, indicating the product's potential impact on patient care and safety in oral surgery [1]