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Respironics DreamWear Silicone Pillows Mask - HSA Registration DE0506546

Access comprehensive regulatory information for Respironics DreamWear Silicone Pillows 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 DE0506546 and owned by Respironics, Inc.. The device was registered on January 03, 2022.

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
DE0506546
Respironics DreamWear Silicone Pillows Mask
HSA Registration Number: DE0506546
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Product Description

This 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 patients (>66 lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506546
Registration Date
January 03, 2022
Retention Due Date
January 02, 2026
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 246 MACPHERSON ROAD, BETIME BUILDING, #03-01, SINGAPORE 348578
Model Information
Model Name(s)
S, DreamWear Silicone Pillows, Small Frame with Headgear, Global M, DreamWear Silicone Pillows, Small Frame with Headgear, Global L, DreamWear Silicone Pillows, Small Frame with Headgear, Global MW, DreamWear Silicone Pillows, Small Frame with Headgear, Global S, DreamWear Silicone Pillows, Medium Frame with Headgear, Global M, DreamWear Silicone Pillows, Medium Frame with Headgear, Global L, DreamWear Silicone Pillows, Medium Frame with Headgear, Global MW, DreamWear Silicone Pillows, Medium Frame with Headgear, Global S, DreamWear Silicone Pillows, Large Frame with Headgear, Global M, DreamWear Silicone Pillows, Large Frame with Headgear, Global L, DreamWear Silicone Pillows, Large Frame with Headgear, Global MW, DreamWear Silicone Pillows, Large Frame with Headgear, Global S, DreamWear Silicone Pillows, Small Frame without Headgear, Global M, DreamWear Silicone Pillows, Small Frame without Headgear, Global L, DreamWear Silicone Pillows, Small Frame without Headgear, Global MW, DreamWear Silicone Pillows, Small Frame without Headgear, Global S, DreamWear Silicone Pillows, Medium Frame without Headgear, Global M, DreamWear Silicone Pillows, Medium Frame without Headgear, Global L, DreamWear Silicone Pillows, Medium Frame without Headgear, Global MW, DreamWear Silicone Pillows, Medium Frame without Headgear, Global S, DreamWear Silicone Pillows, Large Frame without Headgear, Global M, DreamWear Silicone Pillows, Large Frame without Headgear, Global L, DreamWear Silicone Pillows, Large Frame without Headgear, Global MW, DreamWear Silicone Pillows, Large Frame without Headgear, Global DreamWear Silicone Pillows, FitPack, Global DreamWear Silicone Pillows, Setup Pack DreamWear Silicone Pillows, Demo Pack
Model Identifier(s)
1146410 1146411 1146412 1146413 1146414 1146415 1146416 1146417 1146448 1146449 1146450 1146451 1146453 1146454 1146455 1146456 1146457 1146458 1146459 1146460 1146461 1146462 1146463 1146464 1146468 1146470 1146471