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Xper Information Management System - SFDA Registration ME0000003237SFDAA00059

Access comprehensive regulatory information for Xper Information Management System in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000003237SFDAA00059 and manufactured by Philips Medical Systems Nederland B.V..

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 IIa
ME0000003237SFDAA00059
Xper Information Management System
SFDA Registration: ME0000003237SFDAA00059
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Product Information

Software for processing and distribution of diagnostic images & medical patient information.

Product Use

The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/ hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multiโ€channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000003237SFDAA00059
Authorization ID
GHTF-2017-1144
Status
Active
Expire Date
September 01, 2020
Manufacturer
Model Information
Model ID(s)
Xper Information Management System 1.5 Xper Information Management System 2.3
Product Accessories

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