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Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 京械注准20242220634

Access comprehensive regulatory information for Fully automatic chemiluminescence immunoassay analyzer 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20242220634 and owned by Beijing Beier Bioengineering 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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Class II
京械注准20242220634
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
NMPA Registration Number: 京械注准20242220634
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Intended Use
English

该产品基于化学发光法,与配套的检测试剂共同使用,在临床上用于对来源于人体血清、 血浆或者其他体液样本中的被分析物进行体外定性或定量检测.

中文

该产品基于化学发光法,与配套的检测试剂共同使用,在临床上用于对来源于人体血清、 血浆或者其他体液样本中的被分析物进行体外定性或定量检测。

Device Classification
Device Class
Class II
Model Specifications
BR-2000.
BR-2000。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242220634
Approval Date
November 11, 2024
Expiry Date
November 10, 2029
Registrant
Name
Beijing Beier Bioengineering Co., Ltd.
北京贝尔生物工程股份有限公司
Province/Region
Beijing
北京
Address
107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing
北京市大兴区创展路20号院1号楼1层107
Production Facility
Production Address
北京市大兴区创展路20号院
Structure and Composition
English

BR-2000主要由主机(包含样本架输送模块、反应杯配备模块、加样模块、试剂处理模块、温育反应模块、清洗分离模块、光学检测模块、电路控制模块)、软件组件(版本号:1)及附件(包含样本架、液路管)组成.

中文

BR-2000主要由主机(包含样本架输送模块、反应杯配备模块、加样模块、试剂处理模块、温育反应模块、清洗分离模块、光学检测模块、电路控制模块)、软件组件(版本号:1)及附件(包含样本架、液路管)组成。

Storage Conditions and Expiration
English

10 years

中文

10年

Additional Information
Appendix
产品技术要求