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Singapore HSA registration DE0506714

GE Definium Tempo Digital Radiographic Systems

Singapore flagSingapore·CLASS C·GE Hualun Medical Systems Co Ltd·Registered March 10, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506714
Registration Date
March 10, 2022
Retention Due Date
March 09, 2026
Product description
The Definium Tempo Pro/ Definium Tempo 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. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. Optional Dual Energy function enables users to acquire a low-kVp image and a high kVp image to create a soft tissue and bone image. 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)
FlashPad HD 2530 FlashPad HD 3543 FlashPad HD 4343 Definium Tempo Definium Tempo Pro
Model Identifier(s)
5771012 5771417 5771717 Definium Tempo Definium Tempo Pro
About this record

Access comprehensive regulatory information for GE Definium Tempo Digital Radiographic Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506714 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on March 10, 2022.

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 C