Saudi Arabia SFDA registration ME0000006631SFDAA00166
ROTAFLOW Console
Saudi Arabia·Medical Device·Maquet Cardiopulmonary GmbH·Class IIbActiveProduct 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
- Manufacturer Name
- Maquet Cardiopulmonary GmbH
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'}]
About this record
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.
Free DatabasePowered by Pure Global AISFDA Official DataClass IIb