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Fully automatic blood cell analyzer - NMPA Registration 粤械注准20242221565

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20242221565 and owned by Edan Instruments, Inc.. The device was approved on November 25, 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.

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NMPA Official Data
Class II
粤械注准20242221565
Fully automatic blood cell analyzer
全自动血细胞分析仪
NMPA Registration Number: 粤械注准20242221565
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Pricing
Intended Use
English

供临床检验中血液细胞计数、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.

中文

供临床检验中血液细胞计数、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。

Device Classification
Device Class
Class II
Model Specifications
H90、H95、H96、H90S、H95S、H96S、H98S、H99S
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242221565
Approval Date
November 25, 2024
Expiry Date
November 24, 2029
Registrant
Name
Edan Instruments, Inc.
深圳市理邦精密仪器股份有限公司
Province/Region
Guangdong
广东
Address
No. 15, Jinhui Road, Jinsha Community, Kengzi Street, Pingshan New District, Shenzhen
深圳市坪山新区坑梓街道金沙社区金辉路15号
Production Facility
Production Address
深圳市坪山新区坑梓街道金沙社区金辉路15号
Structure and Composition
English

主要由自动进样组件、样本采集分配单元、试剂分配单元、样本检测单元、微处理器控制系统、样本结果输出系统和电源系统组成.

中文

主要由自动进样组件、样本采集分配单元、试剂分配单元、样本检测单元、微处理器控制系统、样本结果输出系统和电源系统组成。