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Singapore HSA registration DE0501088

Respironics Dorma 500 Auto System

Singapore flagSingapore·CLASS B·Respironics, Inc.·Registered January 12, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0501088
Registration Date
January 12, 2018
Retention Due Date
January 11, 2026
Product description
The Philips Respironics Dorma 500 Auto system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
Product Owner
Name
Respironics, Inc.
Short Name
Respironics, Inc.
Address
1001 Murry Ridge Lane, Murrysville, PA 15668, 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)
Performance tubing, 6' (1.83m), White System One Heated Humidifier INT Dorma 500 Auto, INTL Dorma 500 Auto, w/ Humid, INTL
Model Identifier(s)
1032907 IN6H INV501 INV501H
About this record

Access comprehensive regulatory information for Respironics Dorma 500 Auto System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501088 and owned by Respironics, Inc.. The device was registered on January 12, 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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