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Blood lipid control solution - NMPA Registration 湘械注准20252400077

Access comprehensive regulatory information for Blood lipid control solution in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20252400077 and owned by Sinocare Inc.. The device was approved on January 15, 2025.

This page provides complete registration details including registrant information, province location (Hunan), 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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Class II
湘械注准20252400077
Blood lipid control solution
血脂质控液
NMPA Registration Number: 湘械注准20252400077
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Pricing
Intended Use
English

用于血脂指标(总胆固醇和甘油三酯)测试系统检测过程中的质量控制。

Device Classification
Device Class
Class II
Model Specifications
水平1(4mL ×1)、水平2(4mL ×1)
Approval Department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration Information
Registration Number
湘械注准20252400077
Approval Date
January 15, 2025
Expiry Date
January 14, 2030
Registrant
Name
Sinocare Inc.
三诺生物传感股份有限公司
Province/Region
Hunan
湖南
Address
No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone
长沙高新技术产业开发区谷苑路265号
Production Facility
Production Address
长沙高新技术产业开发区谷苑路265号
Structure and Composition
English

由稳定剂(0.001%-2%)、抗菌剂(0.1%-2%)、缓冲液(90%-95%)、甘油(0.01%-2%)和胆固醇(0.01%-2%)组成。

Storage Conditions and Expiration
English

储存条件:储存温度5℃~30℃,储存湿度≤95%RH。 请在规定的储存条件下储存;请勿让阳光长时间直接照射质控液;质控液存放不当,可能对检验结果产生影响。有效期:未开瓶产品的有效期为6个月,开瓶后产品有效期为3个月,两者以先到的日期为准。使用后应立即将瓶盖拧严,并将开瓶日期标注于质控液标签上。

Additional Information
Appendix
产品技术要求、说明书