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Respironics DreamStation Therapy Devices - HSA Registration DE0018371

Access comprehensive regulatory information for Respironics DreamStation Therapy Devices in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018371 and owned by Respironics, Inc.. The device was registered on July 19, 2016.

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
DE0018371
Respironics DreamStation Therapy Devices
HSA Registration Number: DE0018371
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Product Description

Respironics DreamStation Therapy Devices deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0018371
Registration Date
July 19, 2016
Change Notification Approval Date
June 12, 2024
Retention Due Date
July 18, 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)
FlexiWrap (Adult) DreamStation Humidifier, EU DreamStation CPAP w/Humid, INTL DreamStation CPAP, INTL DreamStation CPAP Pro w/Humid, INTL DreamStation CPAP Pro, INTL DreamStation Auto CPAP w/Humid, INTL DreamStation Auto CPAP, INTL DreamStation BiPAP Pro w/Humid, INTL DreamStation BiPAP Pro, INTL DreamStation Auto BiPAP w/Humid, INTL DreamStation Auto BiPAP, INTL 15mm Standard Tube
Model Identifier(s)
954A EUXH INX200H15 INX200S15 INX400H15 INX400S15 INX500H15 INX500S15 INX600H15 INX600S15 INX700H15 INX700S15 PR15