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Singapore HSA registration DE0509562

GE Definium Pace Select Digital Radiographic system

Singapore flagSingapore·CLASS C·GE Hualun Medical Systems Co Ltd·Registered July 22, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0509562
Registration Date
July 22, 2024
Change Notification Approval Date
March 07, 2025
Retention Due Date
July 21, 2025
Product description
The Definium Pace Select is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. This device is not intended for mammographic applications.
Product Owner
Name
GE Hualun Medical Systems Co Ltd
Short Name
GE Hualun Medical Systems Co Ltd
Address
No.1 Yong Chang North Road, Beijing Economic Technological, Development Zone, Beijing, 100176, CHINA
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
Definium Pace Select FlashPad Select
Model Identifier(s)
Definium Pace Select Mars1717X
About this record

Access comprehensive regulatory information for GE Definium Pace Select Digital Radiographic system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509562 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on July 22, 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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