Singapore HSA registration DE0018858
ResMed AirFit F20 Full Face Mask
Singapore·CLASS B·ResMed Pty Ltd·Registered January 03, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0018858
- Registration Date
- January 03, 2017
- Change Notification Approval Date
- November 16, 2023
- Retention Due Date
- January 02, 2026
Product description
The AirFit F20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device. The AirFit F20 is: • to be used by patients weighing more than 30 kg for whom positive airway pressure has been prescribed • intended for single-patient re-use in the home environment and multi-patient re-use in the 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 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)
- AirFit F20 SML Sys - APAC AirFit F20 MED Sys - APAC AirFit F20 LGE Sys - APAC AirFit F20 for Her SML - APAC AirFit F20 for Her MED - APAC AirFit F20 SML Sys - SLM AirFit F20 MED Sys - SLM AirFit F20 LGE Sys - SLM AirFit F20 for Her SML - SLM AirFit F20 for Her MED - SLM AirFit F20 Frame Sys SML AirFit F20 Frame Sys MED AirFit F20 Frame Sys LGE AirFit F20 for Her Frame Sys SML AirFit F20 for Her Frame Sys MED F20 Frame F20 for Her Frame AirFit F20 Cushion SML AirFit F20 Cushion MED AirFit F20 Cushion LGE F20 Headgear SML F20 Headgear STD F20 Headgear LGE F20 for Her Headgear STD F20 Headgear Clip (2pk) F20 Elbow F20 soft sleeves
- Model Identifier(s)
- 63420 63421 63422 63423 63424 63445 63446 63447 63448 63449 63460 63461 63462 63463 63464 63465 63466 63467 63468 63469 63470 63471 63472 63473 63475 63476 63477
About this record
Access comprehensive regulatory information for ResMed AirFit F20 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 DE0018858 and owned by ResMed Pty Ltd. The device was registered on January 03, 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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