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GE OEC One CFD Mobile C-arm X-ray Product - HSA Registration DE0505313

Access comprehensive regulatory information for GE OEC One CFD 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 DE0505313 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on January 06, 2021.

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
DE0505313
GE OEC One CFD Mobile C-arm X-ray Product
HSA Registration Number: DE0505313
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Product Description

The product is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and/or contrast agents during diagnostic, interventional, and surgical procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0505313
Registration Date
January 06, 2021
Change Notification Approval Date
April 08, 2025
Retention Due Date
January 05, 2026
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)
Tube side Laser Aimer  FPD side Laser Aimer OEC One CFD OEC One CFD OEC One CFD OEC One CFD OEC One CFD OEC One CFD
Model Identifier(s)
S20205GA S20205GB  S20205GN S20205GR S20205GS S20205KA S20205KB S20205KC