Singapore HSA registration DE0012069
Philips Respironics AMARA 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
- DE0012069
- Registration Date
- December 31, 2012
- Change Notification Approval Date
- September 19, 2013
- Retention Due Date
- December 30, 2025
Product description
The Amara Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patient (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
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 Respironics Amara Mask w/RS Frame and RS Hgr, Petite Respironics Amara Mask w/RS Frame and RS Hgr, Small Respironics Amara Mask w/ Hgr, Small Respironics Amara Mask w/ Hgr, Medium Respironics Amara Mask w/ Hgr, Large Respironics Amara Mask W/RS Frame and Hgr Int, Medium Respironics Amara Mask 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 1090220 1090221 1090222 1090223 1090224 1090225 1090228 1090288 1090289 1090290 1090292 1090293 1090294 1090296 1090297 1090299
About this record
Access comprehensive regulatory information for Philips Respironics AMARA 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 DE0012069 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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