Singapore HSA registration DE0017602
Respironics Amara View Minimal Contact Full Face Mask
Singapore·CLASS B·Respironics, Inc.·Registered October 28, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
- HSA Product Code
- HSAMDB00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0017602
- Registration Date
- October 28, 2015
- Change Notification Approval Date
- February 18, 2021
- Retention Due Date
- October 27, 2025
Product description
Amara View Minimal Contact Full Face 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 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 Amara View Mask w/o Hgr M Amara View Mask w/o Hgr L Amara View Mask w/o Hgr S Amara View Mask w/Hgr, Intl M Amara View Mask w/Hgr, Intl L Amara View Mask w/Hgr, Intl Amara View Mask w/Hgr, FitPack RP - Amara View Quick-Release Tube RP - S Amara View Cushion RP - M Amara View Cushion RP - L Amara View Cushion RP - Amara View Headgear, L RP - Amara View Headgear, Standard RP - Amara View Headgear Clip, 2 pk RP - Amara View Sizing Gauge
- Model Identifier(s)
- 1090612 1090613 1090614 1090662 1090663 1090664 1090670 1090689 1090692 1090693 1090694 1090696 1090697 1090698 1090699
About this record
Access comprehensive regulatory information for Respironics Amara View Minimal Contact 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 DE0017602 and owned by Respironics, Inc.. The device was registered on October 28, 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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