Pure Global

ResMed Quattro FX Full Face Mask System - HSA Registration DE0014205

Access comprehensive regulatory information for ResMed Quattro FX Full Face 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 DE0014205 and owned by ResMed Ltd. The device was registered on October 30, 2013.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0014205
ResMed Quattro FX Full Face Mask System
HSA Registration Number: DE0014205
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

It channels airflow noninvaseively to a patient from a positive airway pressure device such a a continuous positivie airway pressure (CPAP) or bilevel system. The Quattro FX is: โ€ข to be used by adult patients (> 30 kg) for whom positive airway pressure has been prescribed. โ€ข intended for single-patient re-use in the home and multipatient re-use in the hospital/institutioal environment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration Information
Registration Number
DE0014205
Registration Date
October 30, 2013
Retention Due Date
October 29, 2025
Product Owner
Short Name
ResMed Ltd
Address
1 Elisabeth Macarthur Drive, Bella Vista NSW 2153, AUSTRALIA
Registrant
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model Information
Model Name(s)
Quattro FX FFM SML-SLM Quattro FX FFM MED-SLM Quattro FX FFM LGE-SLM Quattro FX FFM Mask SML-APAC Quattro FX FFM Mask MED-APAC Quattro FX FFM Mask LGE-APAC
Model Identifier(s)
61715 61716 61717 61763 61764 61765