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Singapore HSA registration DE0501734

Respironics DreamStation BiPAP autoSV

Singapore flagSingapore·CLASS C·Respironics, Inc·Registered June 11, 2018
Device classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0501734
Registration Date
June 11, 2018
Change Notification Approval Date
July 12, 2024
Retention Due Date
June 10, 2025
Product description
The device is intended to provide mask-applied non-invasive ventilatory support to adult patients (>30 kg) for the primary treatment of obstructive sleep-disordered breathing with secondary Central Sleep Apnea or Cheyne-Stokes Respiration (CSR). The device may be used in the hospital or home.’
Product Owner
Name
Respironics, Inc
Short Name
Respironics, Inc
Address
1001 Murry Ridge Lane, Murrysville PA 15668-8550, UNITED STATES
Registrant
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
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 AutoSV w/Humid, no Bluetooth Intl DreamStation BiPAP AutoSV no Bluetooth, Intl DreamStation BiPAP AutoSV 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 INX900H19 INX900S19 INX900T19 PR12 PR15
About this record

Access comprehensive regulatory information for Respironics DreamStation BiPAP autoSV in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501734 and owned by Respironics, Inc. The device was registered on June 11, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C