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BeneHeart D3 - SFDA Registration ME0000000143SFDAA00031

Access comprehensive regulatory information for BeneHeart D3 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 ME0000000143SFDAA00031 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
ME0000000143SFDAA00031
BeneHeart D3
SFDA Registration: ME0000000143SFDAA00031
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Product Information

Defibrillator/monitor

Product Use

The equipment is intended for external defibrillation, synchronized cardioversion and semi-automatic defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, SpO2,PR and Resp 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
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000143SFDAA00031
Authorization ID
GHTF-2015-0988
Status
Active
Expire Date
February 21, 2020
Model Information
Model ID(s)
BeneHeart D3
Product Accessories

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