Singapore HSA registration DE0502240
ResMed AirCurve 10 VAuto
Singapore·CLASS B·ResMed Pty Ltd·Registered October 04, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0502240
- Registration Date
- October 04, 2018
- Change Notification Approval Date
- December 23, 2024
- Retention Due Date
- October 03, 2025
Product description
The AirCurve 10 VAuto device is indicated for the treatment of obstructive sleep apnoea (OSA) in patients weighing more than 30 kg or more than 13 kg in CPAP and S modes. 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.
Product Owner
- Name
- ResMed Pty Ltd
- 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)
- Grey Tubing - Cuffed Air 10 – Lumis Series Top Plate SlimLine Tubing S9-AIR 10 FILTER - STD ( 1 PACK) S9-AIR 10 FILTER - STD ( 2 PACK) S9-AIR 10 FILTER - STD ( 12 PACK) S9-AIR 10 FILTER - STD ( 50 PACK) S9-AIR 10 FILTER - HYPO ( 1 PACK) S9-AIR 10 FILTER - HYPO ( 2 PACK) S9-AIR 10 FILTER - HYPO ( 12 PACK) S9-AIR 10 FILTER - HYPO ( 50 PACK) S9 Oximeter Converter Cable ClimateLineAir Heated Tubing Air 10 DC-DC Converter HumidAir Standard Tub HumidAir Cleanable Air 10 USB Module Air10 Oximetry Module RPS II - Air 10 DC Cable ClimateLineAir Oxy Heated Tubing AirCurve 10 VAuto APAC Tri 4G
- Model Identifier(s)
- 14948 27964 36810 36850 36851 36852 36853 36855 36856 36857 36858 36941 37296 37297 37299 37300 37301 37302 37343 37357 37481
About this record
Access comprehensive regulatory information for ResMed AirCurve 10 VAuto in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502240 and owned by ResMed Pty Ltd. The device was registered on October 04, 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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