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Singapore HSA registration DE0016408

Resmed Mirage FX Nasal mask system

Singapore flagSingapore·CLASS B·ResMed Ltd·Registered October 13, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0016408
Registration Date
October 13, 2014
Change Notification Approval Date
August 20, 2018
Retention Due Date
October 12, 2025
Product description
The Mirage FX / Mirage FX for Her channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage FX / Mirage FX for Her Nasal Mask System is: • to be used by patients (>30 kg) for whom positive airway pressure has been prescribed • intended for single-patient re-use in the home and multipatient re-use in the hospital/institutional 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)
Mirage FX Mask Sys – SLM* Mirage FX Mask SYS-AP Mirage FX for Her Mask Sys STD-AP Mirage FX Mask SYS WD-SLM Mirage FX Mask SYS WD-AP Mirage FX for Her Mask Sys-AMER Mirage FX for Her Mask Sys-SLM Mirage FX for Her Mask Sys-EUR1 Mirage FX for Her Mask Sys-EUR2 Mirage FX for Her Mask Sys-ANZ Mirage FX for Her Mask Sys -SML-AP
Model Identifier(s)
62104 62105 62107 62119 62120 62128 62130 62132 62133 62134 62144
About this record

Access comprehensive regulatory information for Resmed Mirage FX Nasal mask 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 DE0016408 and owned by ResMed Ltd. The device was registered on October 13, 2014.

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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