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Singapore HSA registration DE0508775

GE Revolution Apex CT Systems

Singapore flagSingapore·CLASS C·GE Medical Systems LLC·Registered December 20, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0508775
Registration Date
December 20, 2023
Change Notification Approval Date
March 17, 2025
Retention Due Date
December 19, 2025
Product description
The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.
Product Owner
Name
GE Medical Systems LLC
Short Name
GE Medical
Address
3000 North Grandview Blvd, Waukesha, WI 53188, UNITED STATES
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)
Revolution Apex Elite Revolution Apex Plus
Model Identifier(s)
00195278460271  00195278502179
About this record

Access comprehensive regulatory information for GE Revolution Apex CT Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508775 and owned by GE Medical Systems LLC. The device was registered on December 20, 2023.

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