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Singapore HSA registration DE0019108

Respironics Alice NightOne

Singapore flagSingapore·CLASS B·Respironics, Inc.·Registered March 29, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0019108
Registration Date
March 29, 2017
Change Notification Approval Date
August 07, 2020
Retention Due Date
March 28, 2026
Product description
Alice NightOne is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Alice NightOne is intended for use in a supervised (hospital) or unsupervised (home) environment. Alice NightOne is intended as a diagnostic device for adults. No physiological alarms are present. Alice NightOne is not a monitor.
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)
Reusable Finger Sensor (Soft), Large Reusable Finger Sensor (Soft), Medium Reusable Finger Sensor (Soft), Small Sleepware G3 Software V3.9.2 Alice NightOne Durabelt, Adult Alice NightOne Durabelt, Large Alice NightOne System, Wireless, Intl Alice NightOne System, Intl Alice NightOne Nonin SpO2 Cable Reusable Finger Sensor Finger Flex Oximeter Sensor, Adult Pro-Flow, Nasal Cannula, Adult, 16" (40.64cm) Pro-Flow Plus Nasal Oral Cannula, Adult, 16" (40.64cm) Pro-Flow, Nasal Cannula, Adult, 16" (40.64cm)
Model Identifier(s)
1062049 1062050 1062051 1082462 1113310 1113311 1114801 1114803 1119823 936 953 P1328-60 P1343 P1390
About this record

Access comprehensive regulatory information for Respironics Alice NightOne in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019108 and owned by Respironics, Inc.. The device was registered on March 29, 2017.

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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