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Fully automatic thromboelastography analyzer - NMPA Registration 鲁械注准20252220011

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.

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NMPA Official Data
Class II
鲁械注准20252220011
Fully automatic thromboelastography analyzer
全自动血栓弹力图仪
NMPA Registration Number: 鲁械注准20252220011
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DJ Fang

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Pricing
Intended Use
English

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。

Device Classification
Device Class
Class II
Model Specifications
PCD8000。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20252220011
Approval Date
January 03, 2025
Expiry Date
January 02, 2030
Registrant
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 Facility
Production Address
淄博高新区齐祥路3588号
Structure and Composition
English

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。

Additional Information
Appendix
产品技术要求