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Fully automatic fluorescence immunoassay analyzer - NMPA Registration 鲁械注准20242220740

Access comprehensive regulatory information for Fully automatic fluorescence 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 鲁械注准20242220740 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on July 25, 2024.

This page provides complete registration details including registrant information, province location (Shandong), 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
鲁械注准20242220740
Fully automatic fluorescence immunoassay analyzer
全自动荧光免疫分析仪
NMPA Registration Number: 鲁械注准20242220740
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Intended Use
English

与荧光素标记的荧光免疫层析试剂配套使用,用于对人体全血、血清、血浆、尿液样本中的待测物进行体外定量检测.

中文

与荧光素标记的荧光免疫层析试剂配套使用,用于对人体全血、血清、血浆、尿液样本中的待测物进行体外定量检测。

Device Classification
Device Class
Class II
Model Specifications
RapidProII6000.
RapidProII6000。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242220740
Approval Date
July 25, 2024
Expiry Date
July 11, 2029
Registrant
Name
Qingdao Hightop Biotech Co., Ltd.
青岛汉唐生物科技有限公司
Province/Region
Shandong
山东
Address
No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
青岛高新技术产业开发区河东路369号
Production Facility
Production Address
青岛高新技术产业开发区河东路369号、潍坊经济开发区古亭街8877号(委托生产)备注:受托生产企业:山东康华生物医疗科技股份有限公司;统一社会信用代码:91370700266827355D
Structure and Composition
English

全自动荧光免疫分析仪主要由加样系统模块、孵育模块、光学检测模块、数据处理模块、电源供电模块、显示模块、软件组件组成.

中文

全自动荧光免疫分析仪主要由加样系统模块、孵育模块、光学检测模块、数据处理模块、电源供电模块、显示模块、软件组件组成。

Additional Information
Remark
受托生产企业:山东康华生物医疗科技股份有限公司;统一社会信用代码:91370700266827355D
Changes
生产地址由“青岛高新技术产业开发区河东路369号”变更为“青岛高新技术产业开发区河东路369号、潍坊经济开发区古亭街8877号(委托生产)备注:受托生产企业:山东康华生物医疗科技股份有限公司;统一社会信用代码:91370700266827355D”
Appendix
产品技术要求