ResAppDx - India CDSCO Medical Device Registration

ResAppDx is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000517_0c421af028752f744cdf59c028121cd4_ebcc949aa965ef05344207334cd186e8. This device is marketed under the brand name ResAppDx. The license holder is M/S ASIA ACTUAL INDIA (OPC) PVT. LTD., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

ResAppDx

UID: IMP/MD/2022/000517_0c421af028752f744cdf59c028121cd4_ebcc949aa965ef05344207334cd186e8

Brand Name

ResAppDx

License Holder

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Device Class

Class B

Approving Authority

CDSCO

Product Information

ResAppDx is a mobile medical software application (ResAppDx) that analyses cough sounds to aid in diagnosis of a set of respiratory diseases in patients aged 29 days or older by a healthcare provider. The set of respiratory diseases detected are: lower respiratory tract disease, asthma exacerbation/reactive airway disease (ResAppDx), croup (ResAppDx), pneumonia (ResAppDx), bronchiolitis (ResAppDx), COPD (ResAppDx). On iOS platform and select Android devices, COPD exacerbation (ResAppDx) is also detected. ResAppDx is to be used on patients aged 29 days or older who produce involuntary/spontaneous coughs or are able to cooperate in providing voluntary cough sounds. The device provides a qualitative output based on cough analysis to the healthcare provider. ResAppDx is for use under the supervision of a healthcare provider. ResAppDx may be used either directly in a clinic or Emergency Department, or remotely via the telehealth platform.