Singapore HSA registration DE0510576
Globus Medical Excelsius3D™ Imaging System
Singapore·CLASS C·GLOBUS MEDICAL INC·Registered April 10, 2025Device 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 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.
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
About this record
Access comprehensive regulatory information for Globus Medical Excelsius3D™ 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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