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Sodium, potassium, chloride ion concentration detection calibration solution (ion selective electrode method) - NMPA Registration 吉械注准20252400061

Access comprehensive regulatory information for Sodium, potassium, chloride ion concentration detection calibration solution (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20252400061 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20252400061
Sodium, potassium, chloride ion concentration detection calibration solution (ion selective electrode method)
钠、钾、氯离子浓度检测校准品(离子选择电极法)
NMPA Registration Number: 吉械注准20252400061
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Intended Use
English

适用于本集团生产的附电解质分析装置的全自动生化分析仪,测定人血清和尿液中的钠、钾、氯离子浓度时,通过将校准品A和校准品B组合进行测定,以获得离子选择电极的斜率值。

Device Classification
Device Class
Class II
Model Specifications
校准品A:520mL/袋 校准品B:190mL/袋
Approval Department
Jilin Provincial Drug Administration
吉林省药品监督管理局
Registration Information
Registration Number
吉械注准20252400061
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

校准品A 氯化钠120mmol/L、磷酸二氢钠20mmol/L、氯化钾4.0mmol/L、普诺西林3001mmol/L、校准品B 氯化钠32.6mmol/L、磷酸二氢钠37.4mmol/L、氯化钾8.0mmol/L、普诺西林3001mmol/L

Additional Information
Appendix
产品技术要求