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Singapore HSA registration DE0510350

Compumedics Somfit PRO

Singapore flagSingapore·CLASS B·Compumedics Limited·Registered February 18, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510350
Registration Date
February 18, 2025
Retention Due Date
February 17, 2026
Product description
Somfit is a wearable device for collecting patients physiological data, primarily for use in assisting medical professionals to diagnose sleep disorders
Product Owner
Name
Compumedics Limited
Short Name
Compumedics Limited
Address
30-40 Flockhart Street, Abbotsford, Victoria, 3067, AUSTRALIA
Registrant
Name
EASMED ASIA PTE. LTD.
Address
11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
Name
EASMED ASIA PTE LTD
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model information
Model Name(s)
Somfit Charging Plug USB-C Cable Somfit Pro Carry Bag Prep-pad Nasal Canula with filter Somfit sensor electrode Somfit Pro single night consumable pack Respifit ECG Electrodes Respifit Device Respifit charger Somfit Device Charging Cradle
Model Identifier(s)
0437-0004-00 3140-0001-00 4637-0005-00 5400-0062-00 5436-0008-00 7037-1001-00 7037-1005-00 7037-1006-00 8037-0002-00 8037-0102-00 8040-0001-00 8040-0101-00
About this record

Access comprehensive regulatory information for Compumedics Somfit PRO in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510350 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B