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ROTAFLOW Console - SFDA Registration ME0000006631SFDAA00166

Access comprehensive regulatory information for ROTAFLOW Console 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 ME0000006631SFDAA00166 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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Class IIb
ME0000006631SFDAA00166
ROTAFLOW Console
SFDA Registration: ME0000006631SFDAA00166
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Product Information

Heart-Lung Support System

Product Use

Intended for use in an extracorporeal circulation during a cardiopulmonary bypass within the framework of surgical procedures, or in circulatory support. The RF-32 pumps blood within the flow rate range as described.

Device Classification
Risk Class
Class IIb
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000006631SFDAA00166
Authorization ID
MDMA-1-2019-4581
Status
Active
Expire Date
May 26, 2027
Manufacturer
Model Information
Model ID(s)
70104.3290; 70105.1696
Product Accessories

[{'tradeName': 'Sprinter Cart', 'description': 'Accessory to support during extracorporeal circulation with or without an oxygenator', 'gmdn': '1234'}, {'tradeName': 'Sprinter Cart XL', 'description': 'Accessory to support during extracorporeal circulation with or without an oxygenator', 'gmdn': '1234'}]