Singapore HSA registration DE0501910
Respironics Dreamstation GO
Singapore·CLASS B·Respironics, Inc·Registered July 18, 2018Device 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 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.
Product Owner
- Name
- Respironics, Inc
- 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 Go – Small Travel Kit DreamStation Go – 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
About this record
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.
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