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Gendex GXDP-700 Digital Panoramic X-ray System - HSA Registration DE0011402

Access comprehensive regulatory information for Gendex GXDP-700 Digital Panoramic 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 DE0011402 and owned by Gendex Dental Systems. The device was registered on October 22, 2012.

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
DE0011402
Gendex GXDP-700 Digital Panoramic X-ray System
HSA Registration Number: DE0011402
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Product Description

The GXDP-700 is intended to take panoramic, cephalometric and 3D images of the dento-maxillofacial complex of the human skull. It must not be used to take images of any other part of the human body. VixWinโ„ข Platinum is a software program for general dental and maxillo-facial diagnostic imaging. InVivoDental is a software application intended to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, it is used for the simulation and evaluation of dental implants, orthodontics and surgical treatment.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
HSA Product Code
Refer to CRPNS
HS Code
90221300
Registration Information
Registration Number
DE0011402
Registration Date
October 22, 2012
Change Notification Approval Date
January 05, 2015
Retention Due Date
October 21, 2025
Product Owner
Short Name
Gendex Dental System
Address
1910 North Penn Road, Hatfield, Pennsylvania, 19440, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
VixWin Platinum GXDP-700 Panoramic Imaging System GXDP-700 C Panoramic and Cephalometric Imaging System GXDP-700 S Panoramic and 3D CBCT Imaging System GXDP-700 SC Panoramic, 3D CBCT and Cephalometridc Imaging System InVivoDental 5.3
Model Identifier(s)
649-0018 900564 900565 900566 900567 InVivo 5.3