Sleep disordered breathing SDB - India CDSCO Medical Device Registration
Sleep disordered breathing SDB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000795_662c33e8cf26f7e62bd11c0a98eb2b7c_022a73c8cff8f5f1c0c5eb227ed59d02. The license holder is Morulaa Health Tech Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
Morulaa Health Tech Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
The WM090TD and WM 100 TD devices are pressure-controlled, non-invasive, non-life-sustaining therapy devices for the treatment of sleep disordered breathing ##PLACEHOLDER_0## or intermittent treatment of respiratory insufficiency ##PLACEHOLDER_0## by means of a mask. The devices can be used on persons weighing above 30 kg. The CPAP mode can be used on persons above the age of 3 years. The device may only be used on the instruction of a physician. The WM090TD and WM100TD devices are used in clinical facilities and in domestic situations. In domestic situations, the devices are also taken on trips
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