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Compumedics Somfit - HSA Registration DE0510351

Access comprehensive regulatory information for Compumedics Somfit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510351 and owned by Compumedics Limited. The device was registered on February 18, 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
DE0510351
Compumedics Somfit
HSA Registration Number: DE0510351
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Product Description

Somfit is a wearable device for collecting patients physiological data, primarily for use in assisting medical professionals to diagnose sleep disorders.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510351
Registration Date
February 18, 2025
Retention Due Date
February 17, 2026
Product Owner
Short Name
Compumedics Limited
Address
30-40 Flockhart Street, Abbotsford, Victoria, 3067, AUSTRALIA
Registrant
Address
11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model Information
Model Name(s)
USB-C Cable Somfit Carry Bag Somfit sensor electrode Somfit Device Charging Cradle Prep-pad
Model Identifier(s)
3140-0001-00 4640-0001-00 7040-0001-00 8040-0001-00 8040-0101-00 95000016