Saudi Arabia SFDA registration ME0000006631SFDAA00168
GETINGE Rotaflow II Base Unit
Saudi Arabia·MD·Maquet Cardiopulmonary GmbH·Class IIbActiveProduct 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
- Manufacturer Name
- Maquet Cardiopulmonary GmbH
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'}]
About this record
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.
Free DatabasePowered by Pure Global AISFDA Official DataClass IIb