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Singapore HSA registration DE0500527

ResMed S9 VPAP Tx Positive Airway Pressure Therapy System

Singapore flagSingapore·CLASS B·ResMed Ltd·Registered April 19, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0500527
Registration Date
April 19, 2017
Retention Due Date
April 18, 2026
Product description
The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.
Product Owner
Name
ResMed Ltd
Short Name
ResMed Ltd
Address
1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, AUSTRALIA
Registrant
Name
ResMed Asia Pte. Ltd.
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Name
SG MEDICAL PTE LTD
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model information
Model Name(s)
Standard air tubing 3m air tubing Tx Link EasyCare Tx S9 VPAP Tx H5i cleanable tub H5i standard tub SlimLine air tubing 90W power supply unit Antibacterial filter Antibacterial filter Antibacterial filter Antibacterial filter S9 travel bag H5i S9 USB adapter ClimateLine heated air tubing ClimateLine Max Oxy
Model Identifier(s)
14948 14980 25101 25939 36030 36800 36803 36810 36824 36850 36851 36852 36853 36860 36905 36950 36995 36996
About this record

Access comprehensive regulatory information for ResMed S9 VPAP Tx Positive Airway Pressure Therapy 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 DE0500527 and owned by ResMed Ltd. The device was registered on April 19, 2017.

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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