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Singapore HSA registration DE0017393

Compumedics SomniLink SPAP Device

Singapore flagSingapore·CLASS B·Compumedics Limited·Registered August 11, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90189090
Registration information
Registration Number
DE0017393
Registration Date
August 11, 2015
Retention Due Date
August 10, 2025
Product description
Used to deliver fixed or automatically adjusting constant positive airway pressure (CPAP) for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing (non-ventilator dependant) adult patients weighing over 30kg, for use in the home/hospital or institutional environment. The device can also provide humidification of the delivered air to relieve dryness and irritation of the patient airways, which may arise from the use of such a system.
Product Owner
Name
Compumedics Limited
Short Name
Compumedics Limited
Address
30-40 Flockhart Street, Abbotsford, Victoria, 3067, AUSTRALIA
Registrant
Name
MeDeus (S) Pte Ltd
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Importer
Name
MeDeus (S) Pte Ltd
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Model information
Model Name(s)
SomniLink SPAP SomniLink PSG Software V2.10 MASK
Model Identifier(s)
8020 0125 01 8400 0042 01 MASK
About this record

Access comprehensive regulatory information for Compumedics SomniLink SPAP Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017393 and owned by Compumedics Limited. The device was registered on August 11, 2015.

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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