Pure Global

Fully automatic blood cell analyzer - NMPA Registration 粤械注准20172221148

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20172221148 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on March 12, 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
粤械注准20172221148
Fully automatic blood cell analyzer
全自动血细胞分析仪
NMPA Registration Number: 粤械注准20172221148
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

It is suitable for the determination of complete blood count, white blood cell triples and hemoglobin concentration in clinical examination, providing 20 blood parameter indicators and 3 histograms.

中文

适用于临床检验中全血细胞计数、白细胞三分群、血红蛋白浓度的测定,提供20项血液参数指标及3个直方图。

Device Classification
Device Class
Class II
Model Specifications
RT-7200、RT-7300、RT-7500、RT-7800
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20172221148
Approval Date
March 12, 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 is mainly composed of cell counting pool, pipeline system, computer control system and software.

中文

主要由细胞计数池、管路系统、计算机控制系统、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20172401148。