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Telemetry Monitor - SFDA Registration ME0000000143SFDAA00084

Access comprehensive regulatory information for Telemetry Monitor in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000000143SFDAA00084 and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

This page provides complete registration details including product category (Medical Device), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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Class IIb
ME0000000143SFDAA00084
Telemetry Monitor
SFDA Registration: ME0000000143SFDAA00084
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Product Information

Medical display system

Product Use

The TM80 Telemetry Monitor is intended for use on ambulatory adult and pediatric patients to monitor the physiological data of ECG (including arrhythmia analysis and ST segment analysis), heart rate (HR), SpO2, pulse rate (PR), and non-invasive blood pressure (NIBP). The NIBP module BP10 also supports 24-hour dynamic blood pressure measurement for adult and pediatric patients and the measurement results serve as reference for medical staff.

Device Classification
Risk Class
Class IIb
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000143SFDAA00084
Authorization ID
GHTF-2017-1770
Status
Active
Expire Date
February 21, 2020
Model Information
Model ID(s)
TM80
Product Accessories

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