Pure Global

Nox Sleep Assessment System - HSA Registration DE0503708

Access comprehensive regulatory information for Nox Sleep Assessment 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 DE0503708 and owned by Nox Medical. The device was registered on October 04, 2019.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0503708
Nox Sleep Assessment System
HSA Registration Number: DE0503708
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Nox A1 and Nox A1s System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. It is used to measure, record, display, organize, analyze , summarize, and retrieve physiological parameters during sleep and wake in patients greater than 2 years of age. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre- defined reports based on subjectยดs data. The Nox T3 and T3s recorder is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 and T3s application (Noxturnal). The Nox T3 and T3s recorder is intended for patients greater than 2 years of age.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0503708
Registration Date
October 04, 2019
Change Notification Approval Date
March 03, 2023
Retention Due Date
October 03, 2025
Product Owner
Short Name
Nox Medical
Address
Katrinartuni 2, IS-105, Reykjavik, ICELAND
Registrant
Address
360 ORCHARD ROAD, INTERNATIONAL BUILDING, #08-02, SINGAPORE 238869
Importer
Address
3 MOUNT ELIZABETH, MOUNT ELIZABETH HOSPITAL, #12-13, SINGAPORE 228510
Model Information
Model Name(s)
Model 3150 Wrist-Ox2, BLE, Pack WristOx2PulseOximeterPACK Nox T3system Nox T3s System with WristOx2 Nox A1system Nox A1s System with WristOx2 NoxturnalApp Noxturnal CD WristOx2,Model 3150 Nox C1 Kit Nox C1s Kit Soft SensorSMALL-WO2 WristOx2Soft Sensor,medium Nox RIPBelts andCannula Kit -S/M/L Nox RIPBelts andCannula Kit -M Nox A1StarterSensor Kit,Adult Nox A1StarterSensor Kit,Pediatric Nox T3Recorder Nox T3s Recorder Nox A1Recorder Nox A1s Recorder SPO2 3150Wrist Band Nox ServiceKit Nox Service Kit, s PowerAdapter Nox C1Access point
Model Identifier(s)
113410-001 3150 511010 511012 513010 513012 536210 539010 541010 544020 544023 553010 553020 558210 558211 558410 558411 561010 561011 561410 561411 564042 569010 569015 FW7555M/12 SCOM1