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Singapore HSA registration DE0509875

Philips Ultrasound Workspace

Singapore flagSingapore·CLASS B·Philips Ultrasound LLC·Registered October 04, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509875
Registration Date
October 04, 2024
Change Notification Approval Date
December 27, 2024
Retention Due Date
October 03, 2025
Product description
The product 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. The product is not intended to be used for reading of mammography images. Indications for use of the product are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
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)
Ultrasound Workspace
Model Identifier(s)
300013759461
About this record

Access comprehensive regulatory information for Philips Ultrasound Workspace in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509875 and owned by Philips Ultrasound LLC. The device was registered on October 04, 2024.

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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