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ResMed AirTouch F20 - HSA Registration DE0501874

Access comprehensive regulatory information for ResMed AirTouch F20 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501874 and owned by ResMed Pty Ltd. The device was registered on July 11, 2018.

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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CLASS B
DE0501874
ResMed AirTouch F20
HSA Registration Number: DE0501874
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Product Description

The F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as continuous positive airway pressure (CPAP) or bilevel system. The F20 is - To be used by patients weighing more than 30kg from whom positive airway pressure therapy has been prescribed - Intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0501874
Registration Date
July 11, 2018
Change Notification Approval Date
November 16, 2023
Retention Due Date
July 10, 2025
Product Owner
Short Name
ResMed Pty Ltd
Address
1 Elizabeth Macarthur Drive,, Bella Vista, NSW 2153, AUSTRALIA
Registrant
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model Information
Model Name(s)
AirTouch F20 Cushion 3PK - SML AirTouch F20 Cushion 3PK - MED AirTouch F20 Cushion 3PK - LGE AirTouch F20 Starter Kit - SML AirTouch F20 Starter Kit - MED AirTouch F20 Starter Kit - LGE AirTouch F20 Cushion 3PK - S,M,L included AirTouch F20 SML Sys - SLM AirTouch F20 MED Sys - SLM AirTouch F20 LGE Sys - SLM AirTouch F20 for Her SML - SLM AirTouch F20 for Her MED - SLM AirTouch F20 SML Sys - MULTI AirTouch F20 MED Sys - MULTI AirTouch F20 LGE Sys - MULTI AirTouch F20 for Her SML - MULTI AirTouch F20 for Her MED - MULTI AirTouch F20 Starter Pack AirTouch F20 FH Starter Pack AirTouch F20 Cushion SML AirTouch F20 Cushion MED AirTouch F20 Cushion LGE AirTouch F20 SML Sys - APAC AirTouch F20 MED Sys - APAC AirTouch F20 LGE Sys - APAC AirTouch F20 for Her SML - APAC AirTouch F20 for Her MED - APAC F20 Frame F20 for Her Frame F20 Headgear SML F20 Headgear STD F20 Headgear LGE F20 for Her Headgear STD F20 Headgear Clip (2pk) F20 Elbow F20 soft sleeves F20 QuietAir Elbow
Model Identifier(s)
630006 630007 630008 630009 630010 630011 630012 63005 63006 63007 63008 63009 63012 63013 63014 63015 63016 63017 63018 63028 63029 63030 63051 63052 63053 63054 63055 63465 63466 63470 63471 63472 63473 63475 63476 63477 63494