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_864077e669b6cd8a41edbdc605866f55. 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_864077e669b6cd8a41edbdc605866f55

Brand Name

IONM

License Holder

Morulaa Health Tech Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Cadwell Arc Essentia is indicated for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (IONM) and/or clinical studies of patients of all ages. Use of Cadwell Arc Systems are to be administered by a trained medical professional under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in a suitable clinic or operating room.