Singapore HSA registration DE0501643
GE OEC Elite MiniView Mobile C-Arm X-Ray Product
Singapore·CLASS C·GE Hualun Medical Systems Co Ltd·Registered May 15, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0501643
- Registration Date
- May 15, 2018
- Change Notification Approval Date
- October 24, 2023
- Retention Due Date
- May 14, 2025
Product description
The OEC Elite MiniView (mobile mini C-Arm) is intended to provide fluoroscopic images of the patient during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders.
Product Owner
- Short Name
- GE Hualun Medical Systems Co Ltd
- Address
- No.1 Yong Chang North Road, Beijing Economic Technological, Development Zone, Beijing, 100176, CHINA
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- OEC Elite MiniView System OEC Elite MiniView System Wireless DICOM Wireless FootSwitch
- Model Identifier(s)
- OEC Elite MiniView OEC Elite MiniView S10000DE S10000DF
About this record
Access comprehensive regulatory information for GE OEC Elite MiniView Mobile C-Arm X-Ray Product in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501643 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on May 15, 2018.
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