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Nox Medical Nox sleep system - HSA Registration DE0510573

Access comprehensive regulatory information for Nox Medical Nox sleep 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 DE0510573 and owned by Nox Medical. The device was registered on April 10, 2025.

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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CLASS B
DE0510573
Nox Medical Nox sleep system
HSA Registration Number: DE0510573
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Product Description

The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System 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 intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patientโ€™s home.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0510573
Registration Date
April 10, 2025
Retention Due Date
April 09, 2026
Product Owner
Short Name
Nox Medical
Address
Katrinartuni 2, 105 Reykjavik,, IS-105, ICELAND
Registrant
Address
3 ANG MO KIO STREET 62, LINK@AMK, #06-15, SINGAPORE 569139
Importer
Address
3 ANG MO KIO STREET 62, LINK@AMK, #06-15, SINGAPORE 569139
Model Information
Model Name(s)
WristOx2, BLE, Pack Nox T3s System with WristOx2 Nox A1s System with WristOx2 Noxturnal App Noxturnal CD Nox C1s Kit Nox Nasal Pressure Cannula with Filter Soft Sensor Small - W02 Soft Sensor Medium Gray Nox T3s Recorder Nox A1s Recorder Noxturnal Software Nox C1 Access Point
Model Identifier(s)
3150 511012 513012 536210 539010 544023 552010 553010 553020 561011 561411 NOXTURNAL SCOM1