Saudi Arabia SFDA registration ME0000006631SFDAA00003
Blood Monitoring Unit BMU40
Saudi Arabia·Medical Device·Maquet Cardiopulmonary GmbH·Class IIbActiveProduct information
Heart-Lung Support System
Product use
To monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (paO2), temperature (Ta and Tv), oxygen saturation (SvO2), hemoglobin (Hb) and hematocrit (Hct).
Device classification
- Risk Class
- Class IIb
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000006631SFDAA00003
- Authorization ID
- GHTF-2017-2449
- Status
- Active
- Expire Date
- July 09, 2020
Manufacturer
- Manufacturer Name
- Maquet Cardiopulmonary GmbH
Model information
- Model ID(s)
- 70104.0852
Product accessories
[{'tradeName': 'BMU Cell', 'description': None, 'gmdn': '31715'}, {'tradeName': 'BMU Sensor', 'description': None, 'gmdn': '31715'}]
About this record
Access comprehensive regulatory information for Blood Monitoring Unit BMU40 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 ME0000006631SFDAA00003 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