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CurveBeam HiRise Computed Tomography Imaging X-ray System - HSA Registration DE0506572

Access comprehensive regulatory information for CurveBeam HiRise Computed Tomography Imaging X-ray 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 DE0506572 and owned by CurveBeam LLC. The device was registered on January 12, 2022.

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
DE0506572
CurveBeam HiRise Computed Tomography Imaging X-ray System
HSA Registration Number: DE0506572
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Product Description

The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0506572
Registration Date
January 12, 2022
Retention Due Date
January 11, 2026
Product Owner
Short Name
CurveBeam LLC
Address
2800 Bronze Drive Hatfield, Pennsylvania, 19440, UNITED STATES
Registrant
Address
75 BUKIT TIMAH ROAD, BOON SIEW BUILDING, #06-13, SINGAPORE 229833
Importer
Address
75 BUKIT TIMAH ROAD, BOON SIEW BUILDING, #06-13, SINGAPORE 229833
Model Information
Model Name(s)
HiRise HiRise SINGLE FOOT PLATFORM HiRise Flat Platform HiRise UE PLATFORM HiRise UE SHIELD HiRise NWBC PLATFORM GANTRY SHIELD HiRise Knee Plate Flex Shield Top Flex Shield Bottom HiRise Step Assembly Non-Weight Bearing Chair HiRIse NWBC Guide HiRise CALIBRATION KIT
Model Identifier(s)
1040-115 1040-230 2100-75-0 24000-20-0 24000-22-0 24000-24-0 24000-26-0 24000-27-0 24000-30-0 24000-5-1 24000-5-2 24009-0 24100-0 24100-3-0 2911-0