Electroencephalograph - India CDSCO Medical Device Registration
Electroencephalograph is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000915_12116935d3061d711ed0b9ebb8f239aa_d9caca9268e2e847c8c586221dd479d8. This device is marketed under the brand name Allengers. The license holder is Allengers Global Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.
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Brand Name
Allengers
License Holder
Allengers Global Healthcare Private LimitedDevice Class
Approving Authority
Sub Zonal Baddi
Product Information
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of cerebral and extra cerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool. As with the predicate, the information transferred to EEG will be stored, interpreted and printed with software programs. The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics
