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GE OEC Elite MiniView Mobile C-Arm X-Ray Product - HSA Registration DE0501643

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.

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CLASS C
DE0501643
GE OEC Elite MiniView Mobile C-Arm X-Ray Product
HSA Registration Number: DE0501643
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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.

Device 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 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