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CardioHelp Base Unit - SFDA Registration ME0000006631SFDAA00001

Access comprehensive regulatory information for CardioHelp Base Unit 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 ME0000006631SFDAA00001 and manufactured by Maquet Cardiopulmonary GmbH.

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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SFDA Official Data
Class IIb
ME0000006631SFDAA00001
CardioHelp Base Unit
SFDA Registration: ME0000006631SFDAA00001
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Product Information

Heart-Lung Support System

Product Use

The CARDIOHELP System is designed to drive, control, monitor and record an extracorporeal circulation. The CARDIOHELP System also provides interfaces for communication with other devices.

Device Classification
Risk Class
Class IIb
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000006631SFDAA00001
Authorization ID
GHTF-2017-2449
Status
Active
Expire Date
July 09, 2020
Manufacturer
Model Information
Model ID(s)
70104.7999
Product Accessories

[{'tradeName': 'TPO-D', 'description': None, 'gmdn': '47507'}]