Intra Operative Neuro Monitoring Device - India CDSCO Medical Device Registration

Intra Operative Neuro Monitoring Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000568_1a353b19331271a469f74f0bf30f615f_8afbd092e169b4f4cc1af69c0b0bbc6a. This device is marketed under the brand name IONM. The license holder is Morulaa Health Tech 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

Intra Operative Neuro Monitoring Device

UID: IMP/MD/2023/000568_1a353b19331271a469f74f0bf30f615f_8afbd092e169b4f4cc1af69c0b0bbc6a

Brand Name

IONM

License Holder

Morulaa Health Tech Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Cascade IOMAX™ Intraoperative Monitor measures and displays the electrical signals generated by peripheral nerves, muscles and the central nervous system. It has a pulse oximeter to detect and display pulse rate and SpO2 levels in the limbs. The IOMAX acquires, displays, and stores physiologic data generated either spontaneously or elicited by well‐defined stimuli. It is intended for use in clinical evaluation of neurophysiologic status, for pre‐operative and postoperative assessment of neurophysiologic status, and for intraoperative real‐time monitoring of neural pathways. Use of the proposed devices is to be administered under the direction of a licensed physician, surgeon, or neurologist, in a professional healthcare facility environment