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Philips Respironics Amara Gel Mask - HSA Registration DE0014529

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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CLASS B
DE0014529
Philips Respironics Amara Gel Mask
HSA Registration Number: DE0014529
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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.

Device 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 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