Singapore HSA registration DE0510351
Compumedics Somfit
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 description
Somfit is a wearable device for collecting patients physiological data, primarily for use in assisting medical professionals to diagnose sleep disorders.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B