Singapore HSA registration DE0501841
Respironics DreamStation BiPAP Systems
Singapore·CLASS C·Respironics, Inc·Registered July 06, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0501841
- Registration Date
- July 06, 2018
- Change Notification Approval Date
- October 25, 2024
- Retention Due Date
- July 05, 2025
Product description
The BiPAP S/T and AVAPS devices are intended to provide non-invasive ventilatory support to Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency patients weighing over 18 kg. This device may be used in the hospital or home. The BiPAP S/T and AVAPS devices are not intended for life support or invasive ventilation. The device provides Positive Pressure Ventilation and is indicated for assisted ventilation through a noninvasive interface. The device has the capability of providing a back-up rate as needed. The BiPAP S/T and AVAPS devices do not provide ventilation with a guaranteed tidal volume delivery. Patients requiring ventilation at a predetermined tidal volume are not candidates for Pressure Support ventilation.
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 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 VENTURE DRIVE, VISION EXCHANGE, #22-28, SINGAPORE 608526
Model information
- Model Name(s)
- DreamStation Turret Disinfection Aid DreamStation Micro-Flex PR12 Tube Starter Pack DreamStation, 12mm tube Device Adapter, RP PR12 Mask Adaptor, RP 15MM Heated Tube DreamStation BiPAP ST30 AAM w/Humid, no Bluetooth®, INTL DreamStation BiPAP ST30 AAM, no Bluetooth®, INTL DreamStation BiPAP ST30 AAM, w/Humid/Heated Tube, no Bluetooth®, INTL DreamStation BiPAP AVAPS30 AAM, w/Humid, no Bluethooth®, INTL DreamStation BiPAP AVAPS30 AAM, no Bluetooth®, INTL DreamStation BiPAP AVAPS30 AAM, w/Humid/Heated Tube, no Bluetooth®, INTL DreamStation BiPAP AVAPS30AE AAM w/Humid, no Bluetooth, INTL DreamStation BiPAP AVAPS30AE AAM no Bluetooth, INTL DreamStation BiPAP AVAPS30AE AAM w/Humid/Heated Tube, no Bluetooth, INTL DreamStation Micro-Flexible 12mm Tube, RP RP - 15mm Std Tube - DreamStation
- Model Identifier(s)
- 1127627 1128071 1128073 1128074 HT15 INX1030H19 INX1030S19 INX1030T19 INX1130H19 INX1130S19 INX1130T19 INX1131H19 INX1131S19 INX1131T19 PR12 PR15
About this record
Access comprehensive regulatory information for Respironics DreamStation BiPAP Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501841 and owned by Respironics, Inc. The device was registered on July 06, 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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