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Patient Monitoring System - Vietnam Registration 2403034ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Patient Monitoring System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403034ĐKLH/BYT-HTTB and manufactured by SternMed GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ĐẦU TƯ PHÁT TRIỂN BNL.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, Philips Medizin Systeme Böblingen GmbH, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2403034ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403034ĐKLH/BYT-HTTB
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Device Details

Patient Monitoring System
VN: Máy theo dõi bệnh nhân
Risk Class TTBYT Loại C

Registration Details

2403034ĐKLH/BYT-HTTB

000.00.04.G18-231229-0035

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

SternMed GmbH

Technical Details

The Macs 10 patient monitor is a multifunctional device designed to monitor the vital signs of adult, pediatric, and neonatal patients. It features real-time recording and display of parameters such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, respiratory rate, CO2, body temperature, etc., which enable comprehensive analysis of the patient's physiological status. The Macs 20 and Macs 30 patient monitors are multifunctional devices designed to monitor the vital signs of adult, pediatric, and neonatal patients. They feature real-time recording and display of parameters such as ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiratory rate (RESP), body temperature (TEMP), as well as selective monitoring functions such as end-tidal carbon dioxide concentration (EtCO2), invasive blood pressure (IBP), cardiac output (C.O.), anesthetic concentration (AG), and the Cerebral State Index (CSI), etc., which enable comprehensive analysis of the patient's physiological status. The Macs 50 Monitor Screen is designed to be used for monitoring, displaying, reviewing, storing, and alarming multiple physiological parameters of adults, children, and neonates, including ECG, ST-segment analysis, arrhythmia analysis, tachycardia analysis, heart rate (HR), respiratory rate (RR), temperature (Temp), functional oxygen saturation of the pulse (SpO2), heart rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), impedance cardiography (ICG), carbon dioxide (CO2), nitrous oxide (N2O), and total hemoglobin (Sphb), carboxyhemoglobin (SpCO), and methemoglobin (SpMet). The analysis of ICG and ST-segment are applicable only to adults. The following functions are not applicable to neonates: the Cerebral State Index (CSI) monitoring and the total hemoglobin (SCHb), carboxyhemoglobin (SpCO), and methemoglobin (SpMet) monitoring. The EMS module, which includes ECG, respiratory rate, heart rate, SpO2, NIBP parameters, and temperature, is suitable for use during the transfer of patients

Dates and Status

Nov 02, 2024

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