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ResMed AirFit F40 - HSA Registration DE0509066

Access comprehensive regulatory information for ResMed AirFit F40 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509066 and owned by ResMed Pty Ltd. The device was registered on March 15, 2024.

This page provides complete registration details including product owner information, registrant details, 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
DE0509066
ResMed AirFit F40
HSA Registration Number: DE0509066
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Product Description

The AirFit F40 is intended for patients weighing more than 30 kg, who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. It is 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
Ear, Nose & Throat
Registration Information
Registration Number
DE0509066
Registration Date
March 15, 2024
Retention Due Date
March 14, 2026
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
Model Information
Model Name(s)
AIRFIT F40 SYS - SW/STD APAC AIRFIT F40 SYS - M/STD APAC AIRFIT F40 SYS - L/STD APAC AIRFIT F40 STD STPK APAC
Model Identifier(s)
64645 64646 64647 64650