Electroencephalograph system - India CDSCO Medical Device Registration

Electroencephalograph system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000568_9f1dbf8e9e238cfe91d83a0e0a648615_c4fe3dd1b7a1b5b882cde23e9a45dad2. 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

Electroencephalograph system

UID: IMP/MD/2023/000568_9f1dbf8e9e238cfe91d83a0e0a648615_c4fe3dd1b7a1b5b882cde23e9a45dad2

Brand Name

IONM

License Holder

Morulaa Health Tech Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Arc Zenith is an electroneuro diagnostic device that accepts, measures, displays, records, and stores electrical activity of the brain via scalp and intracranial electroencephalography (IONM) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neuro diagnostic evaluations, including EEG and direct cortical stimulation. Zenith is used with Cadwell acquisition software. Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and postoperative testing on patients of all ages