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Blood Monitoring Unit BMU40 - SFDA Registration ME0000006631SFDAA00003

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.

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Class IIb
ME0000006631SFDAA00003
Blood Monitoring Unit BMU40
SFDA Registration: ME0000006631SFDAA00003
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Product 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
Model Information
Model ID(s)
70104.0852
Product Accessories

[{'tradeName': 'BMU Cell', 'description': None, 'gmdn': '31715'}, {'tradeName': 'BMU Sensor', 'description': None, 'gmdn': '31715'}]