Pure Global

Fully automatic biochemical analyzer - NMPA Registration 粤械注准20242221685

Access comprehensive regulatory information for Fully automatic biochemical 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 粤械注准20242221685 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on December 19, 2024.

This page provides complete registration details including registrant information, province location (Guangdong), 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
粤械注准20242221685
Fully automatic biochemical analyzer
全自动生化分析仪
NMPA Registration Number: 粤械注准20242221685
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

与适配试剂配合使用,用于人体样本中待测物的定量分析.电解质模块用于检测人体样本中K离子、Na离子、C1离子的含量.

中文

与适配试剂配合使用,用于人体样本中待测物的定量分析。电解质模块用于检测人体样本中K离子、Na离子、C1离子的含量。

Device Classification
Device Class
Class II
Model Specifications
Chemray 2000、Chemray 2020
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242221685
Approval Date
December 19, 2024
Expiry Date
December 18, 2029
Registrant
Name
Rayto Life and Analytical Sciences Co., Ltd.
深圳雷杜生命科学股份有限公司
Province/Region
Guangdong
广东
Address
The second floor of Building 5, Software Park, No. 2, Gaoxin Zhongsan Road, Yuehai Street, Nanshan District, Shenzhen
深圳市南山区粤海街道高新中三道二号软件园五号楼二层
Production Facility
Production Address
深圳市光明新区高新东片区双明大道南侧雷杜工业大厦
Structure and Composition
English

全自动生化分析仪由分析部(主机)、操作部(操作与分析软件)、结果输出部、附件及耗材组成.

中文

全自动生化分析仪由分析部(主机)、操作部(操作与分析软件)、结果输出部、附件及耗材组成。

Additional Information
Appendix
产品技术要求