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ResMed Lumis 150 VPAP - HSA Registration DE0017946

Access comprehensive regulatory information for ResMed Lumis 150 VPAP in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017946 and owned by ResMed Pty Ltd. The device was registered on March 16, 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 B
DE0017946
ResMed Lumis 150 VPAP
HSA Registration Number: DE0017946
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Product Description

The Lumis 150 VPAP ST device is indicated to provide non-invasive ventilation for patients weighing more than 13 kg or more than 30 kg in iVAPS mode with respiratory insufficiency or obstructive sleep apnoea (OSA). It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0017946
Registration Date
March 16, 2016
Change Notification Approval Date
December 23, 2024
Retention Due Date
March 15, 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
Importer
Address
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)
Lumis 150 VPAP ST Lumis 150 VPAP ST ANZ TRI 4G Lumis 150 VPAP ST-A Lumis 150 VPAP ST-A ANZ TRI 4G Slimline Tubing ClimateLineAir Air 10 DC-DC Converter HumidAir Standard Tub HumidAir Cleanable Air 10 USB Air 10 Oximetry ClimateLineAir Oxy
Model Identifier(s)
28119 28125 28207 28226 36810 37296 37297 37299 37300 37301 37302 37357