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Fully automatic blood cell analyzer - NMPA Registration 粤械注准20172221133

Access comprehensive regulatory information for Fully automatic blood cell 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20172221133 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on March 07, 2022.

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.

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NMPA Official Data
Class II
粤械注准20172221133
Fully automatic blood cell analyzer
全自动血细胞分析仪
NMPA Registration Number: 粤械注准20172221133
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DJ Fang

DJ Fang

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Intended Use
English

It is suitable for the detection of white blood cell count (WBC), red blood cell count (RBC), platelet count (PLT), hematocrit (HCT) and hemoglobin concentration (HGB) and white blood cell quintile count.

中文

适用于白细胞数目(WBC)、红细胞数目(RBC)、血小板数目(PLT)、红细胞压积(HCT)和血红蛋白浓度(HGB)的检测及白细胞五分群计数。

Device Classification
Device Class
Class II
Model Specifications
Hemaray 81、Hemaray 82、Hemaray 83、Hemaray 85、Hemaray 86、Hemaray 88、Hemaray 89
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20172221133
Approval Date
March 07, 2022
Expiry Date
June 26, 2027
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

It consists of cell counting cell, tubing system, computer control system and software.

中文

由细胞计数池、管路系统、计算机控制系统及软件组成。

Storage Conditions and Expiration
English

26-JUN-27

Additional Information
Remark
原产品注册证号:粤械注准20172401133。