Singapore HSA registration DE0012065
Philips Respironics Amara SE Full Face Mask
Singapore·CLASS B·Philips Respironics, Inc.·Registered December 31, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDB00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0012065
- Registration Date
- December 31, 2012
- Change Notification Approval Date
- September 19, 2013
- Retention Due Date
- December 30, 2025
Product description
The Amara SE Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients (>66 lbs/30kg) who are appropriate candidates for noninvasive ventilation.
Product Owner
- Short Name
- Philips Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville,Pennslyvania 15668-8550, UNITED STATES
Registrant
- Address
- 622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
- Address
- 25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 3 MOUNT ELIZABETH, MOUNT ELIZABETH HOSPITAL, #12-13, SINGAPORE 228510 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763 2 JALAN RAJAH, GOLDEN WALL FLATTED FACTORY, #05-20, SINGAPORE 329134 246 MACPHERSON ROAD, BETIME BUILDING, #03-01, SINGAPORE 348578
Model information
- Model Name(s)
- Forehead pad Talon headgear clips Amara mask SE with reduced size frame and reduced size headgear Petite Amara mask SE with reduced size frame and reduced size headgear Small Amara mask SE with headgear Small Amara mask SE with headgear Medium Amara mask SE with headgear Large Respironics Amara Mask SE W/RS Frame and Hgr Int, Medium Respironics Amara Mask SE W/RS Frame and Hgr Int, Large RS Frame Frame Cushion, Petite Cushion, Small Cushion, Medium Cushion, Large RS headgear Headgear Sizing gauge
- Model Identifier(s)
- 1040114 1071877 1090230 1090231 1090232 1090233 1090234 1090235 1090236 1090288 1090289 1090290 1090292 1090293 1090294 1090296 1090297 1090299
About this record
Access comprehensive regulatory information for Philips Respironics Amara SE 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 DE0012065 and owned by Philips Respironics, Inc.. The device was registered on December 31, 2012.
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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