MRI Multipara Monitoring System - India CDSCO Medical Device Registration

MRI Multipara Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000595_3555c2d7a990881d4695724b4b063e05_c64d6dd49f2f315a608db32834372f17. This device is marketed under the brand name FRED PA-1. The license holder is Schiller Healthcare India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

MRI Multipara Monitoring System

UID: IMP/MD/2021/000595_3555c2d7a990881d4695724b4b063e05_c64d6dd49f2f315a608db32834372f17

Brand Name

FRED PA-1

License Holder

Schiller Healthcare India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The MAGLIFE RT-1 is a patient monitor designed for use in the vicinity of MRI devices with magnetic fields between 0.2 and 3 Tesla. It is used for the monitoring of a patient during MRI procedures. An authorized person must be present throughout the procedure. Depending on their configuration, the monitoring function of the MAGLIFE RT- 1 delivers the most important parameters – ECG, SpO2, Capnography Respiration rate, NIBP, IBP, Temperature, Anesthetic Agents and Basic ventilation mechanics – and allows continuous monitoring of the patient with alarming for each parameter if value is out of limits.