Telemetry monitoring system - NMPA Registration 国械注准20243071865
Access comprehensive regulatory information for Telemetry monitoring system in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243071865 and owned by Edan Instruments, Inc.. The device was approved on September 19, 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.
The product is intended to be used in healthcare settings by or under the guidance of a healthcare professional. It is suitable for monitoring, alarming and storing physiological parameters of ECG (including ST segment, QT and arrhythmia analysis), respiration (RESP), heart rate (HR), blood oxygen saturation (SpO2), respiration rate (RR), pulse rate (PR), body temperature (TEMP), non-invasive blood pressure (NIBP) and continuous non-invasive blood pressure (CNBP, suitable for people over 12 years old) for adults and children. Provides continuous monitoring of mobile and non-mobile adults and children, which can be used at the bedside or worn on the patient.
该产品预期在医疗机构由专业临床医护人员或在专业临床医护人员的指导下使用。适用于对成人和小儿进行生理参数心电（含ST段、QT和心律失常分析）、呼吸（RESP）、心率（HR）、血氧饱和度（SpO2）、呼吸率（RR）、脉率（PR）、体温（TEMP）、无创血压（NIBP）和连续无创血压（CNBP，适用于12岁以上人群）的监测、报警、存储，生理参数可发送至理邦中央监护系统软件，支持本地监护功能，提供对移动和非移动的成人及小儿的连续监护，可在床旁使用或佩戴在病人身上使用。
The product consists of a main unit, a telemetry receiver box (AP608), a centralized charging station (CS-10), a battery, a power cord and accessories. Please refer to the product technical requirements for details.
该产品由主机、遥测接收箱（AP608）、集中充电站（CS-10）、电池、电源线和附件组成。详见产品技术要求。