Singapore HSA registration DE0017697
Respironics DreamWear Nasal Mask with Under the Nose Cushion
Singapore·CLASS B·Respironics, Inc.·Registered December 04, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
- HSA Product Code
- HSAMDB00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0017697
- Registration Date
- December 04, 2015
- Change Notification Approval Date
- August 26, 2020
- Retention Due Date
- December 03, 2025
Product description
Respironics DreamWear Nasal Mask with Under the Nose Cushion is intended to provide an interface for application of Continuous Positive Airway Pressure (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 or bi-level therapy has been prescribed.
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)
- S DreamWear Under the Nose Nasal, Med Frame w/HGR, GBL M DreamWear Under the Nose Nasal, Med Frame w/HGR, GBL L DreamWear Under the Nose Nasal, Med Frame w/HGR, GBL MW DreamWear Under the Nose Nasal, Med Frame w/HGR, GBL S DreamWear Under the Nose Nasal, Sm Frame w/HGR, GBL M DreamWear Under the Nose Nasal, Sm Frame w/HGR, GBL L DreamWear Under the Nose Nasal, Sm Frame w/HGR, GBL MW DreamWear Under the Nose Nasal, Sm Frame w/HGR, GBL S DreamWear Under the Nose Nasal, Lg Frame w/HGR, GBL M DreamWear Under the Nose Nasal, Lg Frame w/HGR, GBL L DreamWear Under the Nose Nasal, Lg Frame w/HGR, GBL MW DreamWear Under the Nose Nasal, Lg Frame w/HGR, GBL DreamWear Under the Nose Nasal, FitPack DreamWear Under the Nose Nasal, Med Frame w/HGR, GBL DreamWear Under the Nose Nasal, Med Frame w/o HGR, GBL S DreamWear Under the Nose Nasal, Med Frame w/o HGR, GBL M DreamWear Under the Nose Nasal, Med Frame w/o HGR, GBL L DreamWear Under the Nose Nasal, Med Frame w/o HGR, GBL MW DreamWear Under the Nose Nasal, Med Frame w/o HGR, GBL S DreamWear Under the Nose Nasal, Sm Frame w/o HGR, GBL M DreamWear Under the Nose Nasal, Sm Frame w/o HGR, GBL L DreamWear Under the Nose Nasal, Sm Frame w/o HGR, GBL MW DreamWear Under the Nose Nasal, Sm Frame w/o HGR, GBL S DreamWear Under the Nose Nasal, Lg Frame w/o HGR, GBL M DreamWear Under the Nose Nasal, Lg Frame w/o HGR, GBL L DreamWear Under the Nose Nasal, Lg Frame w/o HGR, GBL MW DreamWear Under the Nose Nasal, Lg Frame w/o HGR, GBL DreamWear Under the Nose Nasal, Medium Frame W/HGR, Intl S, DreamWear Under the Nose Nasal Cushion, RP M, DreamWear Under the Nose Nasal Cushion, RP L, DreamWear Under the Nose Nasal Cushion, RP MW, DreamWear Under the Nose Nasal Cushion, RP DreamWear Small Frame, RP DreamWear Medium Frame, RP DreamWear Large Frame, RP DreamWear Headgear, RP DreamWear UTN Nasal Sizing Gauge, RP DreamWear Fabric Wraps, RP
- Model Identifier(s)
- 1116680 1116681 1116682 1116683 1116685 1116686 1116687 1116688 1116690 1116691 1116692 1116693 1116695 1116700 1116701 1116705 1116706 1116707 1116708 1116710 1116711 1116712 1116713 1116715 1116716 1116717 1116718 1116720 1116740 1116741 1116742 1116743 1116745 1116746 1116747 1116750 1116752 1116754
About this record
Access comprehensive regulatory information for Respironics DreamWear Nasal Mask with Under the Nose Cushion in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017697 and owned by Respironics, Inc.. The device was registered on December 04, 2015.
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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