Singapore HSA registration DE0502685
Respironics DreamWear Full Face Mask
Singapore·CLASS B·Respironics, Inc·Registered January 17, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0502685
- Registration Date
- January 17, 2019
- Change Notification Approval Date
- December 16, 2019
- Retention Due Date
- January 16, 2026
Product description
This 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 (>66lbs/30kg) for whom CPAP therapy 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)
- Small, DreamWear Full, Small & Medium Frame, International Medium,, DreamWear Full, Small & Medium Frame, International Large, DreamWear Full, Small & Medium Frame, International Medium Wide, DreamWear Full, Small & Medium Frame, International
- Model Identifier(s)
- 1133370 1133371 1133372 1133373
About this record
Access comprehensive regulatory information for Respironics DreamWear Full Face 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 DE0502685 and owned by Respironics, Inc. The device was registered on January 17, 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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