Singapore HSA registration DE0506189
GE Revolution Apex system
Singapore·CLASS C·GE Medical Systems LLC·Registered September 20, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0506189
- Registration Date
- September 20, 2021
- Change Notification Approval Date
- August 29, 2024
- Retention Due Date
- September 19, 2025
Product description
The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.
Product Owner
- Short Name
- GE Medical
- Address
- 3000 North Grandview Blvd, Waukesha, WI 53188, UNITED STATES
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)
- Revolution Apex Boom-in-a-room for Linux SmartStep Kit, Ctrl & Ft
- Model Identifier(s)
- 840682146616 5115174-30 5149705-4
About this record
Access comprehensive regulatory information for GE Revolution Apex 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 DE0506189 and owned by GE Medical Systems LLC. The device was registered on September 20, 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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