近日，正海生物（Zhenghai Bio-Tech）宣布成功取得国家药品监督管理局（NMPA）颁发的医疗器械注册证，标志着其又一创新产品正式获准上市。该注册证涉及的产品为公司自主研发的口腔修复膜，主要用于牙周组织再生和口腔颌面外科手术中的软组织修复。作为国内领先的生物材料企业，正海生物长期专注于再生医学领域，尤其在口腔、神经和整形修复等细分市场拥有深厚技术积累。此次获批不仅丰富了公司产品线，也进一步巩固了其在口腔再生医学领域的领先地位。口腔修复膜作为高值耗材，具有较高的技术壁垒和临床价值，其获批将有助于提升公司在公立医院及民营口腔机构的市场渗透率。未来，正海生物将继续加大研发投入，推动更多创新型生物医用材料走向临床应用，助力中国高端医疗器械的国产化进程。
Recently, Zhenghai Bio-Tech announced that it has successfully obtained a medical device registration certificate from China’s National Medical Products Administration (NMPA), marking official approval for the market launch of another innovative product. The certified product is an oral regenerative membrane independently developed by the company, primarily used for periodontal tissue regeneration and soft tissue repair in oral and maxillofacial surgeries. As a leading domestic biomaterials company, Zhenghai Bio-Tech has long focused on regenerative medicine, with deep technical expertise in specialized areas such as oral, neurological, and reconstructive surgery. This approval not only expands the company’s product portfolio but also strengthens its leadership position in the field of oral regenerative medicine. As a high-value consumable with significant clinical value and technical barriers, the approved membrane is expected to enhance Zhenghai’s market penetration in both public hospitals and private dental clinics. Moving forward, Zhenghai Bio-Tech will continue to increase R&D investment to bring more innovative biomedical materials into clinical use, supporting the localization of high-end medical devices in China.
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