Pure Global

Fully Automated Hematology Analyzer - NMPA Registration 渝械注准20242220512

Access comprehensive regulatory information for Fully Automated Hematology 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 渝械注准20242220512 and owned by Zybio Inc.. The device was approved on December 24, 2024.

This page provides complete registration details including registrant information, province location (Chongqing), 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
渝械注准20242220512
Fully Automated Hematology Analyzer
全自动血液细胞分析仪
NMPA Registration Number: 渝械注准20242220512
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

供临床检验中作血液细胞计数、白细胞五分类、血红蛋白浓度测量、网织红细胞测量、有核红细胞测量、体液细胞测量、C反应蛋白及血清淀粉样蛋白A测量.

中文

供临床检验中作血液细胞计数、白细胞五分类、血红蛋白浓度测量、网织红细胞测量、有核红细胞测量、体液细胞测量、C反应蛋白及血清淀粉样蛋白A测量。

Device Classification
Device Class
Class II
Model Specifications
EXZ 8000Pro、EXZ 8010Pro、EXZ 8020Pro
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20242220512
Approval Date
December 24, 2024
Expiry Date
December 23, 2029
Registrant
Name
Zybio Inc.
中元汇吉生物技术股份有限公司
Province/Region
Chongqing
重庆
Address
重庆市大渡口区跳磴镇石林大道45号
Production Facility
Production Address
重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层、5层A区;重庆市大渡口跳磴镇海兴路333号建桥生物医药园附3号第1-5层、附4号第1-5层;重庆市大渡口区建桥工业园C区太康路3号24-25栋2层A区
Structure and Composition
English

由分析部(选配:微量血自动混匀模块、内置扫码模块)、自动进样器(有单机使用的规格A 、级联使用的规格B或联合使用的规格C供选择)、急诊模块(有封闭进样规格D或开放进样规格E供选择)、信息管理部、结果输出部和软件组成.其中软件为内嵌型软件组件.

中文

由分析部(选配:微量血自动混匀模块、内置扫码模块)、自动进样器(有单机使用的规格A 、级联使用的规格B或联合使用的规格C供选择)、急诊模块(有封闭进样规格D或开放进样规格E供选择)、信息管理部、结果输出部和软件组成。其中软件为内嵌型软件组件。

Additional Information
Remark
首次注册。