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离子多项质控物 - NMPA Registration 京械注准20242400632

Access comprehensive regulatory information for 离子多项质控物 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400632 and owned by Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.. The device was approved on November 11, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20242400632
离子多项质控物
NMPA Registration Number: 京械注准20242400632
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Pricing
Intended Use
English

与本公司生产的试剂盒配套使用,用于钾、钠、镁、铁、锌、铜项目的室内质量控制.

中文

与本公司生产的试剂盒配套使用,用于钾、钠、镁、铁、锌、铜项目的室内质量控制。

Device Classification
Device Class
Class II
Model Specifications
水平1:1ml;1ml;2;1ml;3;1ml;4;1ml;5;2ml;2ml;2;2ml;3;2ml;4;2ml;5;水平2:1ml;1ml;2;1ml;3;1ml;4;1ml;5;2ml;2ml;2;2ml;3;2ml;4;2ml;5.
水平1:1ml;1ml;2;1ml;3;1ml;4;1ml;5;2ml;2ml;2;2ml;3;2ml;4;2ml;5;水平2:1ml;1ml;2;1ml;3;1ml;4;1ml;5;2ml;2ml;2;2ml;3;2ml;4;2ml;5。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400632
Approval Date
November 11, 2024
Expiry Date
November 10, 2029
Registrant
Name
Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.
北京北检·新创源生物技术有限公司
Province/Region
Beijing
北京
Address
1-5-1, 1st to 2nd floor, Building 1, No. 18 Keyuan Road, Daxing District Industrial Development Zone, Beijing
北京市大兴区工业开发区科苑路18号1幢1至2层1-5-1
Production Facility
Production Address
北京市大兴区工业开发区科苑路18号1幢1至2层1-5-1
Structure and Composition
English

本产品为冻干品.质控物质控范围有批间差异,具体浓度见靶值表.

中文

本产品为冻干品。质控物质控范围有批间差异,具体浓度见靶值表。

Storage Conditions and Expiration
English

2 °C ~ 8 °C protected sealed storage, valid for 12 months.

中文

2℃~8℃避光密封储存,有效期12个月。