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Singapore HSA registration DE0500331

Ambu AuraFlex Single Use Laryngeal Mask

Singapore flagSingapore·CLASS B·Ambu A/S·Registered June 23, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0500331
Registration Date
June 23, 2015
Change Notification Approval Date
May 23, 2019
Retention Due Date
June 22, 2025
Product description
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.
Product Owner
Name
Ambu A/S
Short Name
Ambu A/S
Address
Baltorpbakken 13, DK-2750 Ballerup., Denmark, DENMARK
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model information
Model Name(s)
Ambu® AuraFlex Disposable Flexible Laryngeal Mask Ambu® AuraFlex Disposable Flexible Laryngeal Mask Ambu® AuraFlex Disposable Flexible Laryngeal Mask Ambu® AuraFlex Disposable Flexible Laryngeal Mask Ambu® AuraFlex Disposable Flexible Laryngeal Mask Ambu® AuraFlex Disposable Flexible Laryngeal Mask
Model Identifier(s)
327200000 327250000 327300000 327400000 327500000 327600000
About this record

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.

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