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GETINGE Rotaflow II Base Unit - SFDA Registration ME0000006631SFDAA00168

Access comprehensive regulatory information for GETINGE Rotaflow II 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 ME0000006631SFDAA00168 and manufactured by Maquet Cardiopulmonary GmbH.

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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Class IIb
ME0000006631SFDAA00168
GETINGE Rotaflow II Base Unit
SFDA Registration: ME0000006631SFDAA00168
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Product Information

Centrifugal pump system

Product Use

Intended to drive, control and to monitor an extracorporeal circulation.

Device Classification
Risk Class
Class IIb
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000006631SFDAA00168
Authorization ID
GHTF-2021-1533
Status
Active
Expire Date
May 26, 2024
Manufacturer
Model Information
Model ID(s)
70107.4178
Product Accessories

[{'tradeName': 'Rotaflow II Drive (Flex)', 'description': 'Accessory to drive Rotaflow II disposable', 'gmdn': '3082138'}, {'tradeName': 'Rotaflow II Drive (Compact)', 'description': 'Accessory to drive Rotaflow II disposable', 'gmdn': '3082138'}, {'tradeName': 'Rotaflow II Drive Unit', 'description': 'Accessory to drive Rotaflow II disposable', 'gmdn': '3082138'}, {'tradeName': 'BS', 'description': 'Bubble sensor', 'gmdn': '3082138'}, {'tradeName': 'FBS ', 'description': 'Flow Bubble Sensor', 'gmdn': '3082138'}]