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Respironics DreamWisp Nasal Mask - HSA Registration DE0503176

Access comprehensive regulatory information for Respironics DreamWisp Nasal 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 DE0503176 and owned by Respironics, Inc.. The device was registered on May 31, 2019.

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
DE0503176
Respironics DreamWisp Nasal Mask
HSA Registration Number: DE0503176
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Product Description

This nasal mask is intended to provide an interface for application of Continuous Positive Airway Pressure (CPAP) or bi-level therapy to patients. The mask is intended 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
DE0503176
Registration Date
May 31, 2019
Change Notification Approval Date
September 22, 2020
Retention Due Date
May 30, 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)
FitPk, DreamWisp Nsl, MED Con W/ HGR INT P, DreamWisp Nasal Mask, Med Connector,  W/HGR, INT S, DreamWisp Nasal Mask, Med Connector,  W/HGR, INT M, DreamWisp Nasal Mask, Med Connector,  W/HGR, INT L, DreamWisp Nasal Mask, Med Connector,  W/HGR, INT XL, DreamWisp Nasal Mask, Med Connector,  W/HGR, INT
Model Identifier(s)
1137921 1137942 1137943 1137944 1137945 1137946