Pure Global

ResMed AirFit P10 Nasal Pillows System - HSA Registration DE0017524

Access comprehensive regulatory information for ResMed AirFit P10 Nasal Pillows System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017524 and owned by ResMed Pty Ltd. The device was registered on October 02, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0017524
ResMed AirFit P10 Nasal Pillows System
HSA Registration Number: DE0017524
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The AirFit P10 channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The AirFit P10 is: ๏‚ท to be used by patients (>30 kg) for whom positive airway pressure has been prescribed ๏‚ท intended for single-patient re-use in the home and multipatient re-use in the hospital/institutional environment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration Information
Registration Number
DE0017524
Registration Date
October 02, 2015
Change Notification Approval Date
April 11, 2023
Retention Due Date
October 01, 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)
AirFit P10 Mask SYSTEM-ANZ AirFit P10 Mask SYSTEM-APAC AirFit P10 for Her SYSTEM-ANZ AirFit P10 for Her SYSTEM-APAC AirFit P10 Frame SYS X-SMALL AirFit P10 Frame SYS SMALL AirFit P10 Frame SYS MEDIUM AirFit P10 Frame SYS LARGE AirFit P10 Pillow X-SMALL AirFit P10 Pillow SMALL AirFit P10 Pillow MEDIUM AirFit P10 Pillow LARGE AirFit P10 Adjustable Headgear AirFit P10 for Her Adjustable HG AirFit P10 Frame (1pk)
Model Identifier(s)
62904 62905 62914 62915 62920 62921 62922 62923 62930 62931 62932 62933 62935 62936 62938