Singapore HSA registration DE0014529
Philips Respironics Amara Gel Mask
Singapore·CLASS B·Respironics, Inc.·Registered December 23, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDB00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0014529
- Registration Date
- December 23, 2013
- Retention Due Date
- December 22, 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 multipatient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Product Owner
- Short Name
- Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, 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)
- Silicone Pillow Forehead Pad RP Trueblue Hgr Clips RP-RS Amara Frame RP Amara Frame RP-P Amara Cushion RP-S Amara Cushion RP-M Amara Cushion RP-L Amara Cushion RP-RS Amara Headgear RP Amara Headgear RP-Amara Sizing Gauge P Amara Gel Mask w/RS Frame and RS Hgr Int S Amara Gel Mask w/RS Frame and RS Hgr Int S Amara Gel Mask w/Hgr Int M Amara Gel Mask w/Hgr Int L Amara Gel Mask w/Hgr Int M Amara Gel Mask w/RS Frame and RS Hgr Int L Amara Gel Mask w/RS Frame and Hgr Int
- Model Identifier(s)
- 1040114 1071877 1090288 1090289 1090290 1090292 1090293 1090294 1090296 1090297 1090299 1090420 1090421 1090422 1090423 1090424 1090425 1090426
About this record
Access comprehensive regulatory information for Philips Respironics Amara Gel 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 DE0014529 and owned by Respironics, Inc.. The device was registered on December 23, 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.
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