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Singapore HSA registration DE0500275

Ambu® AuraGain Single Use Laryngeal Mask

Singapore flagSingapore·CLASS B·Ambu A/S·Registered December 01, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration information
Registration Number
DE0500275
Registration Date
December 01, 2014
Change Notification Approval Date
May 23, 2019
Retention Due Date
November 30, 2025
Product description
Intended for use as an alternative to a face mask for achieving and maintaining control of the airway during routine and emergency anaesthetic procedures.
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® AuraGain Ambu® AuraGain Ambu® AuraGain Ambu® AuraGain Ambu® AuraGain Ambu® AuraGain Ambu® AuraGain Ambu® AuraGain
Model Identifier(s)
408 100 000 408 150 000 408 200 000 408 250 000 408 300 000 408 400 000 408 500 000 408 600 000
About this record

Access comprehensive regulatory information for Ambu® AuraGain 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 DE0500275 and owned by Ambu A/S. The device was registered on December 01, 2014.

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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