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Singapore HSA registration DE0019244

Philips Lumify Ultrasound System

Singapore flagSingapore·CLASS B·Philips Ultrasound LLC·Registered May 15, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0019244
Registration Date
May 15, 2017
Change Notification Approval Date
March 20, 2025
Retention Due Date
May 14, 2025
Product description
The Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, the Combined Mode (B+Color), and M-Mode. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac and lung. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
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)
Transducer Cable Transducer Cable Lumify Power Module Lumify Lumify Ultrasound System Lumify Diagnostic Ultrasound System iOS L12-4 Transducer Philips Lumify C5-2 Transducer S4-1 Transducer
Model Identifier(s)
453561854691 453561871781 453561998452 453562163981 795005 795161 989605434813 989605449841 989605450353 989605458222
About this record

Access comprehensive regulatory information for Philips Lumify Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019244 and owned by Philips Ultrasound LLC. The device was registered on May 15, 2017.

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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