Pure Global

Respironics Dreamstation GO - HSA Registration DE0501910

Access comprehensive regulatory information for Respironics Dreamstation GO in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501910 and owned by Respironics, Inc. The device was registered on July 18, 2018.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0501910
Respironics Dreamstation GO
HSA Registration Number: DE0501910
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Philips Respironics DreamStation Go systems 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. The DreamStation Go Heated Humidifier is an accessory for the Philips Respironics DreamStation Go therapy devices to provide moisture to the patient circuit. It is intended for use in spontaneously breathing patients weighing over 30kg (66 lbs), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501910
Registration Date
July 18, 2018
Change Notification Approval Date
May 03, 2021
Retention Due Date
July 17, 2025
Product Owner
Short Name
Respironics, Inc
Address
1001 Murry Ridge Lane, Murrysville PA 15668-8550, 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)
DreamStation Goย โ€“ย Small Travel Kit DreamStation Goย ย โ€“ Medium Travel Kit DreamStation Go Battery Pack DreamStation Go Reusable Pollen Filter - 2pk DreamStation Go Disposable 30-Day Fine Filter 6-pk DreamStation Go Auto CPAP with Bluetooth, UK DreamStation Go Auto CPAP with Bluetooth, FSS, UK DreamStation Go heated humidifier, International DreamStation Micro-Flexible 12mm Tubing, RP
Model Identifier(s)
1133275 1133276 1133281 1133743 1133744 GBG500S15 GBG502S15 INGH PR12