血小板聚集仪质控品
- Device class
- Class II
- Model specifications
- 组分R1R2R3规格11;10ml1;10ml1;10ml规格22;10ml2;10ml2;10ml规格34;10ml4;10ml4;10ml规格41;100ml1;100ml1;100ml
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20252400003
- Approval date
- January 02, 2025
- Expiry date
- January 01, 2030
- Name
- Beijing Lepu Medical Technology Co., Ltd.北京乐普诊断科技股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 37, Chaoqian Road, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区超前路37号
- Production address
- 北京市昌平区利祥路6号4幢、5幢、6幢
适用于光电比浊法检测原理的血小板聚集仪的每日检测前的质量控制。
试剂盒由R1、R2和R3组成。主要组成成分为5g/L硫酸肼、50g/L六次甲基四胺、纯化水。注：不同批号试剂盒中各组分不可互换。
2℃~8℃密封避光保存，有效期为12个月。
Access comprehensive regulatory information for 血小板聚集仪质控品 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20252400003 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on January 02, 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.