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Globus Medical Excelsius3Dโ„ข Imaging System - HSA Registration DE0510576

Access comprehensive regulatory information for Globus Medical Excelsius3Dโ„ข Imaging 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 DE0510576 and owned by GLOBUS MEDICAL INC. The device was registered on April 10, 2025.

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
DE0510576
Globus Medical Excelsius3Dโ„ข Imaging System
HSA Registration Number: DE0510576
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Product Description

Excelsius3D is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high X-ray attenuation such as bony anatomy and metallic objects. Excelsius3D images are compatible with image guided systems such as ExcelsiusGPS.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510576
Registration Date
April 10, 2025
Change Notification Approval Date
April 24, 2025
Retention Due Date
April 09, 2026
Product Owner
Short Name
GLOBUS MEDICAL INC
Address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, UNITED STATES
Registrant
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Model Information
Model Name(s)
Excelsius3D Mobile Monitor
Model Identifier(s)
6161.1 6161.21