Heated Humidifier - India CDSCO Medical Device Registration

Heated Humidifier is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000553_da9ccafd717a7db2d62f5f00e3f121cf_546cd894137c6e920dabf50d453b8a21. 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

Heated Humidifier

UID: IMP/MD/2023/000553_da9ccafd717a7db2d62f5f00e3f121cf_546cd894137c6e920dabf50d453b8a21

Brand Name

OmniLab Advanced +

License Holder

PHILIPS INDIA LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

The System One Heated Humidifier is an accessory for the Philips Respironics REMstar and BiPAP therapy devices to provide moisture to the patient circuit. It is intended for use in spontaneously breathing patients weighing over 30 kg (OmniLab Advanced + ), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy

Class B

Heated Humidifier

Brand: Inspired

India Medtronic Private Limited

Class B

Brand: OmniLab Advanced +

Class B