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Patient monitors - NMPA Registration 粤械注准20242071016

Access comprehensive regulatory information for Patient monitors 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20242071016 and owned by Edan Instruments, Inc.. The device was approved on July 31, 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20242071016
Patient monitors
病人监护仪
NMPA Registration Number: 粤械注准20242071016
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Pricing
Intended Use
English

The product is operated by qualified physicians in medical units for monitoring of ECG, respiration, body temperature, pulse oximetry, non-invasive blood pressure, and end-tidal carbon dioxide in adults, children, and neonates.

中文

该产品在医疗单位中供有资质的医师操作,对成人、小儿和新生儿进行心电、呼吸、体温、脉搏血氧饱和度、无创血压、呼气末二氧化碳的监护。

Device Classification
Device Class
Class II
Model Specifications
RespArray
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242071016
Approval Date
July 31, 2024
Expiry Date
July 30, 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

The RespArray patient monitor consists of a host and corresponding functional accessories (ECG cable, non-invasive blood pressure cuff, blood oxygen sensor, body temperature sensor, carbon dioxide gas measurement assembly).

中文

RespArray病人监护仪由主机和相应功能附件(心电电缆、无创血压袖套、血氧传感器、体温传感器、二氧化碳气体测量组件)组成。

Additional Information
Appendix
产品技术要求