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Compumedics Somte PSG - HSA Registration DE0505073

Access comprehensive regulatory information for Compumedics Somte PSG in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505073 and owned by Compumedics Limited. The device was registered on October 27, 2020.

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
DE0505073
Compumedics Somte PSG
HSA Registration Number: DE0505073
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Product Description

The Somte PSG is intended for use in the recording , displaying, analysis. printing and storage of human biological pararmeters such as heart and muscle actively, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders The Somte PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somte PSG is only to be used under the direction of a physician.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0505073
Registration Date
October 27, 2020
Retention Due Date
October 26, 2025
Product Owner
Short Name
Compumedics Limited
Address
30-40 Flockhart Street, Abbotsford, Victoria, 3067, AUSTRALIA
Registrant
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Importer
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Model Information
Model Name(s)
Somte PSG Profusion Sleep 4
Model Identifier(s)
9023-0002-01 9107-0050-01