Shoulder joint prosthesis - NMPA Registration 国械注准20253130020
Access comprehensive regulatory information for Shoulder joint prosthesis in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253130020 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 06, 2025.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
作为生物型肩关节假体使用，适用于初次肩关节置换。
由标准型肱骨柄、反置式肱骨头、反置式关节盂、肩胛盂固定器、间隔器、螺钉、螺帽组成。标准型肱骨柄、螺钉表面处理方式为纯钛粉喷涂，喷涂材料符合ASTM F1580-2012标准规定；肩胛盂固定器为Ti6Al4V粉末使用电子束熔融工艺制造，化学成分应符合GB/T 13810-2017标准要求，力学性能应符合YY0117.1-2005标准要求。标准型肱骨柄选用符合YY 0117.1-2005标准规定的Ti6Al4V锻件制造；间隔器、螺钉、螺帽选用符合GB/T 13810-2017标准规定的TC4棒材制造；反置式肱骨头选用符合YY0117.3-2005标准规定的钴铬钼（CoCrMo）铸件制造；关节盂选用符合GB/T 19701.2-2016标准规定的2型超高分子量聚乙烯（UHMWPE）材料制造。产品经辐照灭菌，灭菌有效期5年。