Fully automatic thromboelastography analyzer
- Device class
- Class II
- Model specifications
- PCD8000。
- Approval department
- Shandong Provincial Drug Administration山东省药品监督管理局
- Registration number
- 鲁械注准20252220011
- Approval date
- January 03, 2025
- Expiry date
- January 02, 2030
- Name
- Shinva Medical Instrument Co., Ltd.山东新华医疗器械股份有限公司
- Province/Region
- Shandong山东
- Address
- Xinhua Medical Science and Technology Park, Zibo High-tech Industrial Development Zone, Shandong Province山东省淄博市高新技术产业开发区新华医疗科技园
- Production address
- 淄博高新区齐祥路3588号
与本公司生产的血栓弹力图检测试剂配套使用，采用凝固法，用于对全血样本进行凝血和抗凝、纤溶和抗纤溶功能的分析。
全自动血栓弹力图仪由主机、电线组件和软件组成，其中主机由预处理模块、耗材模块、机械臂模块、检测模块、温控模块、控制单元、显示单元、机架和外壳组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Fully automatic thromboelastography analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20252220011 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on January 03, 2025.
This page provides complete registration details including registrant information, province location (Shandong), 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.