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Singapore HSA registration DE0507345

ResMed Quattro Air Full Face Mask

Singapore flagSingapore·CLASS B·ResMed Pty Ltd·Registered October 04, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0507345
Registration Date
October 04, 2022
Retention Due Date
October 03, 2025
Product description
The Quattro Air is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Quattro Air is: - to be used by patients (weighing >30 kg) for whom positive airway pressure therapy has been prescribed - intended for single-patient reuse in the home environment and multipatient reuse in the hospital/institutional environment.
Product Owner
Name
ResMed Pty Ltd
Short Name
ResMed Pty Ltd
Address
1 Elizabeth Macarthur Drive,, Bella Vista, NSW 2153, AUSTRALIA
Registrant
Name
ResMed Asia Pte. Ltd.
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Name
ZZENITH MEDICAL ALLIANCE PTE. LTD.
Address
101 IRRAWADDY ROAD, ROYAL SQUARE MEDICAL CENTRE, #11-05, SINGAPORE 329565
Model information
Model Name(s)
Quattro Air FFM SML - APAC Quattro Air FFM MED - APAC Quattro Air FFM LGE - APAC Quattro Air for Her XSML - APAC Quattro Air for Her SML - APAC Quattro Air for Her MED - APAC
Model Identifier(s)
62717 62718 62719 62772 62773 62774
About this record

Access comprehensive regulatory information for ResMed Quattro Air Full Face 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 DE0507345 and owned by ResMed Pty Ltd. The device was registered on October 04, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B