Ambu AuraFlex Single Use Laryngeal Mask - HSA Registration DE0500331
Access comprehensive regulatory information for Ambu AuraFlex Single Use Laryngeal Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500331 and owned by Ambu A/S. The device was registered on June 23, 2015.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Ambu AuraFlex is intended for use as an alternative to a facemask for achieving and maintaining control of the airway during routine and emergency anaesthetic procedures in fasted patients. The Ambu AuraFlex 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 AuraFlex may also be used to establish a clear airway during resuscitation in profoundly unconscious patients with absent glossopharyngeal and laryngeal reflexes who may need artificial ventilation. The device is not intended for use as a replacement of the endotracheal tube, and is best suited for use in surgical procedures where tracheal intubation is not deemed necessary.