Saudi Arabia SFDA registration ME0000006631SFDAA00005
ROTAFLOW Drive
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
- ME0000006631SFDAA00005
- Authorization ID
- GHTF-2017-2449
- Status
- Active
- Expire Date
- July 09, 2020
Manufacturer
- Manufacturer Name
- Maquet Cardiopulmonary GmbH
Model information
- Model ID(s)
- 70102.2161
Product accessories
[{'tradeName': 'ROTAFLOW Emergency Drive', 'description': None, 'gmdn': ''}]
About this record
Access comprehensive regulatory information for ROTAFLOW Drive 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 ME0000006631SFDAA00005 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