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Singapore HSA registration DE0017376

GE Optima XR646 Digital Radiographic System

Singapore flagSingapore·CLASS C·GE Hualun Medical Systems Co Ltd·Registered July 30, 2015
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration information
Registration Number
DE0017376
Registration Date
July 30, 2015
Change Notification Approval Date
June 06, 2018
Retention Due Date
July 29, 2025
Product description
The Optima XR646 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 is intended for use in all routine radiography exams. The 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, 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)
X-ray tube OVER HEAD TUBE SUSPENSION Detector System Cabinet Wallstand Wallstand Radiographic Table Table Wallstand Workstation PC Generator Digital Radiographic System
Model Identifier(s)
46-155400G284 5139720 5340000-7 5397035 GCEWS-C1 GCMWS-C6 GCTBL-C2 GCTBL-C6 GCWS-C1 HP Z420 JEDI 80 RD 1T Optima XR646
About this record

Access comprehensive regulatory information for GE Optima XR646 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 DE0017376 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on July 30, 2015.

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