Laryngeal Mask - India CDSCO Medical Device Registration

Laryngeal Mask is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000283_652145a12b98e17ddf113b031fd0716a_6903d305ef376861648f364e280eee7f. This device is marketed under the brand name Ambu® Silicone Face Mask. The license holder is AMBU INDIA PVT. LTD., and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Laryngeal Mask

UID: IMP/MD/2023/000283_652145a12b98e17ddf113b031fd0716a_6903d305ef376861648f364e280eee7f

Brand Name

Ambu® Silicone Face Mask

License Holder

AMBU INDIA PVT. LTD.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Ambu Aura40 is intended for use as an alternative to the facemask for achieving and maintaining control of the airway during routine and emergency anaesthetic procedures in fasted patients. The Ambu Aura40 may also be used where unexpected difficulties arise in connection with airway management. The mask may also be preferred in some critical airway situations. The Ambu Aura40 may also be used to establish a clear airway during resuscitation in the profoundly unconscious patient with absent glossopharyngeal and laryngeal reflexes who may need artificial ventilation. The device is not intended for use as a replacement for the endotracheal tube and is best suited for use in surgical procedures where tracheal intubation is not deemed necessary

Class A

Brand: Ambu WhiteSensor

Class B