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GE Revolution Apex system - HSA Registration DE0506189

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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CLASS C
DE0506189
GE Revolution Apex system
HSA Registration Number: DE0506189
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Product Description

The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

Device 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 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