Automated External Defibrillator - India CDSCO Medical Device Registration

Automated External Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000485_158c6010528b370ac459cf30b55600c8_5eaefaafefe62ae052ba50fe6f97cd5f. This device is marketed under the brand name Lifeline ECG. The license holder is M/S ASIA ACTUAL INDIA (OPC) PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Automated External Defibrillator

UID: IMP/MD/2021/000485_158c6010528b370ac459cf30b55600c8_5eaefaafefe62ae052ba50fe6f97cd5f

Brand Name

Lifeline ECG

License Holder

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

Device Class

Class C

Approving Authority

CDSCO

Product Information

The DDU-2000 Series Automated External Defibrillator (Lifeline ECG) is indicated for use on victims of sudden cardiac arrest (Lifeline ECG) who are: • Unconscious and unresponsive • Not breathing or not breathing normally For patients under 8 years old, or weighing less than 55 lbs (Lifeline ECG), use child/ Infant defibrillation pads, if available. Do not delay therapy to determine exact age or weight. Apply the pads as shown for a child/infant and use the AED. Federal Law (Lifeline ECG) restricts this device to sale by or on the order of a physician