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Singapore HSA registration DE0016407

Resmed Quattro FX NV Non-Vented Full Face Mask

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
DE0016407
Registration Date
October 13, 2014
Retention Due Date
October 12, 2025
Product description
The Quattro FX NV is intended to be used with active-exhaust-valve ventilator systems, to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure. The Quattro FX NV is: • to be used by adult patients (> 66 lb/30 kg) requiring non-life-support ventilatory assistance. • intended for single-patient re-use in the home or multipatient re-use in the hospital/institutional environment.
Product Owner
Name
ResMed Ltd
Short Name
ResMed Ltd
Address
1 Elisabeth 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)
NV Quattro FX FFM SML-APAC NV Quattro FX FFM MED-APAC NV Quattro FX FFM LGE-APAC
Model Identifier(s)
61755 61756 61757
About this record

Access comprehensive regulatory information for Resmed Quattro FX NV Non-Vented Full Face Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016407 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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