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Sodium, potassium, and chloride ion concentration detection quality control product (ion-selective electrode method) - NMPA Registration 吉械注准20252400062

Access comprehensive regulatory information for Sodium, potassium, and chloride ion concentration detection quality control product (ion-selective electrode method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 吉械注准20252400062 and owned by Jilin Base Egg Biological Technology Co., Ltd.. The device was approved on January 21, 2025.

This page provides complete registration details including registrant information, province location (Jilin), 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
吉械注准20252400062
Sodium, potassium, and chloride ion concentration detection quality control product (ion-selective electrode method)
钠、钾、氯离子浓度检测质控品(离子选择电极法)
NMPA Registration Number: 吉械注准20252400062
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Intended Use
English

适用于附电解质分析装置的本集团的全自动生化分析仪,用于体外定量测定人血清和尿液中的钠、钾、氯离子浓度时的质量控制。

Device Classification
Device Class
Class II
Model Specifications
质控品水平1(正常数值):10mL/瓶 质控品水平2(异常高数值):10mL/瓶 质控品水平3(异常低数值):10mL/瓶
Approval Department
Jilin Provincial Drug Administration
吉林省药品监督管理局
Registration Information
Registration Number
吉械注准20252400062
Approval Date
January 21, 2025
Expiry Date
January 20, 2030
Registrant
Name
Jilin Base Egg Biological Technology Co., Ltd.
吉林基蛋生物科技有限公司
Province/Region
Jilin
吉林
Address
No. 1399, Ya'an Road, Beihu Science and Technology Development Zone, Changchun City, Jilin Province
吉林省长春市北湖科技开发区雅安路1399号
Production Facility
Production Address
吉林省长春市北湖科技开发区雅安路1399号
Structure and Composition
English

质控品水平1 氯化钠80-120mmol/L、磷酸二氢钠30-60mmol/L、氯化钾3.0-5.0mmol/L、普诺西林3001mmol/L、质控品水品2 氯化钠80-150mmol/L、磷酸二氢钠30-90mmol/L、氯化钾3.0-10mmol/L、普诺西林3001mmol/L、质控品水品3 氯化钠60-120mmol/L、磷酸二氢钠10-60mmol/L、氯化钾1-5mmol/L、普诺西林3001mmol/L

Additional Information
Appendix
产品技术要求