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Defibrillator/Monitor - SFDA Registration ME0000000143SFDAA00032

Access comprehensive regulatory information for Defibrillator/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 ME0000000143SFDAA00032 and manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd..

This page provides complete registration details including product category (MD), 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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SFDA Official Data
Class IIb
ME0000000143SFDAA00032
Defibrillator/Monitor
SFDA Registration: ME0000000143SFDAA00032
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Product Information

Defibrillator/monitor

Product Use

The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion andsemi-automatic defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG , SpO2, PR, NIBP, CO2, IBP and Temp monitoring. The equipment is for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.

Device Classification
Risk Class
Class IIb
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000000143SFDAA00032
Authorization ID
MDMA-1-2019-2907
Status
Active
Expire Date
May 26, 2024
Model Information
Model ID(s)
BeneHeart D6 BeneHeart D3
Product Accessories

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