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ResMed Astral Ventilators - HSA Registration DE0018222

Access comprehensive regulatory information for ResMed Astral Ventilators in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018222 and owned by ResMed Pty Ltd. The device was registered on June 03, 2016.

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 C
DE0018222
ResMed Astral Ventilators
HSA Registration Number: DE0018222
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Product Description

The Astral 100/150 device provides continuous or intermittent ventilatory support for patients weighing more than 5 kg who require mechanical ventilation. The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0018222
Registration Date
June 03, 2016
Change Notification Approval Date
June 13, 2024
Retention Due Date
June 02, 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)
Circuit Double smooth bore 22mm water traps Circuit Double smooth bore 15mm water traps Circuit Double smooth bore 22mm Circuit Double smooth bore 15mm Circuit Double smooth bore 10mm Circuit Double Corrugated 22mm water traps Circuit Double Corrugated 15mm water traps Circuit Double Corrugated 22mm Circuit Double Corrugated 15mm Circuit Single smooth bore 22mm Circuit Single smooth bore 15mm Circuit Single smooth bore 22mm Humidified Circuit Single smooth bore 15mm Humidified Circuit Single Corrugated 22mm Circuit Single Corrugated 15mm Circuit Doube Coaxial (baine circuit insp limb is inside the exp limb) Circuit Single Corrugated 22mm incl water traps (Astral - QuickConnect) Circuit Single Corrugated 15mm water traps (Astral - QuickConnect) Circuit Double Corrugated heated 22mm Chamber Circuit Double Corrugated heated 22mm Circuit Double Corrugated heated 15mm Chamber Circuit Double Corrugated heated 15mm Circuit Single Corrugated heated 22mm (Astral - QuickConnect) Circuit Single Corrugated heated 15mm (Astral - QuickConnect) Catheter Mnt s/bore w/Port 22F Catheter Mnt Corr W/port 22F Catheter Mnt Ped 15M Mouthpiece Ang 15M Mouthpiece Ang 17cm tube 22F Mouthpiece Ang 15F/22M Filter HMEF HMEF HMEF Astral 100 Astral 150 Remote Alarm II Hospital Trolley Astral Table Stand Astral Mobility Bag Astral External Battery HME HME HME HME Double limb Adapter Single limb valve Adaptor Single limb leak Adaptor Astral SlimFit Mobility Bag MPV Circuit Support Arm Double Limb Adapter CC - Astral
Model Identifier(s)
21301 21302 21303 21304 21305 21306 21307 21308 21309 21311 21312 21313 21314 21321 21322 21323 21324 21325 21331 21332 21333 21334 21335 21336 21341 21342 21343 21351 21353 21354 24966 24967 24968 24969 27082 27088 27902 27914 27915 27917 27918 27920 27921 27922 27923 27940 27941 27942 27949 27955 27980