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Fully automatic chemiluminescence immunoassay analyzer - NMPA Registration 湘械注准20242221239

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 湘械注准20242221239 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on December 05, 2024.

This page provides complete registration details including registrant information, province location (Hunan), 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
湘械注准20242221239
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
NMPA Registration Number: 湘械注准20242221239
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Intended Use
English

本产品适用于对人体全血、血清、血浆、尿液、脑脊髓液、外泌体样本中的各种被分析物进行定量和定性检测.

中文

本产品适用于对人体全血、血清、血浆、尿液、脑脊髓液、外泌体样本中的各种被分析物进行定量和定性检测。

Device Classification
Device Class
Class II
Model Specifications
Sunlight 300
Approval Department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration Information
Registration Number
湘械注准20242221239
Approval Date
December 05, 2024
Expiry Date
December 04, 2029
Registrant
Name
Hunan Yonghe-sun Biotechnology Co., Ltd.
湖南永和阳光生物科技股份有限公司
Province/Region
Hunan
湖南
Address
No. 101, Kangtian Road, Liuyang Economic and Technological Development Zone
浏阳经济技术开发区康天路101号
Production Facility
Production Address
浏阳经济技术开发区康天路101号
Structure and Composition
English

全自动化学发光免疫分析仪由进样模块、加样模块、温育模块、清洗分离模块、测量模块、试剂管理模块、反应杯管理模块、液路模块、电路控制模块、操作电脑和随机软件(V1.0)组成.

中文

全自动化学发光免疫分析仪由进样模块、加样模块、温育模块、清洗分离模块、测量模块、试剂管理模块、反应杯管理模块、液路模块、电路控制模块、操作电脑和随机软件(V1.0)组成。

Additional Information
Appendix
产品技术要求