Singapore HSA registration DE0012083

Philips Respironics REMStar SE CPAP System

Singapore flagSingapore·CLASS B·Philips Respironics, Inc.·Registered January 03, 2013
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0012083
Registration Date
January 03, 2013
Change Notification Approval Date
November 24, 2020
Retention Due Date
January 02, 2026
Product description
The Philips Respironics REMstar SE systems deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). They are for use in the home or hospital/institutional environment.
Product Owner
Short Name
Philips Respironics, Inc.
Address
1010 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)
SD Card, 10 per pack SD Card Mailers, 10 per pack RemStar SE with Heated Humidifier, SD Slot RemStar SE with SD Slot RemStar SE with Heated Tube Humidifier, SD Slot System One Heated Humidifier System One Heated Tube Humidifier
Model Identifier(s)
1063859 1065146 IN221HS IN221S IN221TS IN6H IN6T
About this record

Access comprehensive regulatory information for Philips Respironics REMStar SE CPAP 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 DE0012083 and owned by Philips Respironics, Inc.. The device was registered on January 03, 2013.

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 B