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Ceruloplasmin quality control material - NMPA Registration 国械注准20223401234

Access comprehensive regulatory information for Ceruloplasmin quality control material in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20223401234 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on September 09, 2022.

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 III
国械注准20223401234
Ceruloplasmin quality control material
铜蓝蛋白质控品
NMPA Registration Number: 国械注准20223401234
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Intended Use
English

This product is used for quality control of ceruloplasmin testing items.

中文

本产品用于铜蓝蛋白检测项目的质量控制。

Device Classification
Device Class
Class III
Model Specifications
Low-value controls: 1×1mL; 1×3mL. High-value controls: 1×1mL; 1×3mL.
低值质控品:1×1mL;1×3mL。高值质控品:1×1mL;1×3mL。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20223401234
Approval Date
September 09, 2022
Expiry Date
September 08, 2027
Registrant
Name
Beijing Leadman Biochemistry Co., Ltd.
北京利德曼生化股份有限公司
Province/Region
Beijing
北京
Address
No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京市北京经济技术开发区兴海路5号
Production Facility
Production Address
北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
Structure and Composition
English

Two levels of liquid controls. Contains phosphate buffer (10 mM), ceruloplasmin, sodium azide (0.01%).

中文

两个水平的液态质控品。含磷酸盐缓冲液(10mM),铜蓝蛋白,叠氮钠(0.01%)。

Storage Conditions and Expiration
English

Store at 2 °C ~ 8 °C, valid for 18 months.

中文

在2℃~8℃保存,有效期为18个月。

Additional Information
Appendix
产品技术要求、说明书