Singapore HSA registration DE0500722
Philips Respironics DreamWear Gel Pillows Mask
Singapore·CLASS B·Respironics, Inc·Registered October 09, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0500722
- Registration Date
- October 09, 2017
- Change Notification Approval Date
- August 26, 2020
- Retention Due Date
- October 08, 2025
Product description
The Philips Respironics DreamWear Gel Pillows 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/30 kg) for whom CPAP or bi-level therapy has been prescribed.
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)
- DreamWear Gel Plw, Med Frm, W/ HGR, INTL
- Model Identifier(s)
- 1125024
About this record
Access comprehensive regulatory information for Philips Respironics DreamWear Gel 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 DE0500722 and owned by Respironics, Inc. The device was registered on October 09, 2017.
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B