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Singapore HSA registration DE0508569

Philips TOMTEC-ARENA

Singapore flagSingapore·CLASS B·Philips Ultrasound LLC·Registered October 13, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508569
Registration Date
October 13, 2023
Retention Due Date
October 12, 2025
Product description
TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images.
Product Owner
Name
Philips Ultrasound LLC
Short Name
Philips Ultrasound LLC
Address
22100 Bothell Everett Highway, Bothell, Washington, 98021-8431, UNITED STATES
Registrant
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model information
Model Name(s)
TOMTEC Arena
Model Identifier(s)
TTA2
About this record

Access comprehensive regulatory information for Philips TOMTEC-ARENA in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508569 and owned by Philips Ultrasound LLC. The device was registered on October 13, 2023.

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