Polysomnography System - India CDSCO Medical Device Registration

Polysomnography System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000553_77172cf2040f814c0e1c4a7dc5f2151a_913b9f6dbb11dd24bd90e4eaaa4e7fa2. This device is marketed under the brand name OmniLab Advanced + . The license holder is PHILIPS INDIA LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Polysomnography System

UID: IMP/MD/2023/000553_77172cf2040f814c0e1c4a7dc5f2151a_913b9f6dbb11dd24bd90e4eaaa4e7fa2

Brand Name

OmniLab Advanced +

License Holder

PHILIPS INDIA LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Alice 6 System is a Polysomnography System (OmniLab Advanced + ) that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper-based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders. This device does not provide alarms and, is not intended for use as an automated apnea monitor