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Nox Sleep System - HSA Registration DE0509911

Access comprehensive regulatory information for 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 DE0509911 and owned by Nox Medical. The device was registered on October 15, 2024.

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
DE0509911
Nox Sleep System
HSA Registration Number: DE0509911
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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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509911
Registration Date
October 15, 2024
Retention Due Date
October 14, 2025
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 Pulse Oximeter Nox A1s Recorder A1 EEG Head Cable, Adult Nox Abdomen Cable, s Nox Cannula with Filter A1 EEG 5 Lead Gold Electrode Cable Nox SAS Head Cable Snap-on Double Lead Orange 50/100 cm Snap-on Double Lead Grey 148/150 cm Snap-on Double Lead Black 148/150 cm Nox SAS Body Cable, Left Nox SAS Body Cable, Right Noxturnal Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox RIP Belts Disposable Nox C1 Access Point
Model Identifier(s)
3150BLE APSG1SEU APSGH1PAC1 ATC1SPAC1 CANAF ECUP5AU1PAC1 ESNAP10SASLMPAC1 ESNAP1PAC1 ESNAP2PAC1 ESNAP3PAC1 ESNAP4SASLMPAC1 ESNAP4SASRMPAC1 NOXTURNAL RIPDL2 RIPDL20 RIPDM2 RIPDM20 RIPDP2 RIPDP20 RIPDS2 RIPDS20 RIPDXL14 RIPDXL2 SCOM1