Singapore HSA registration DE0011402
Gendex GXDP-700 Digital Panoramic X-ray System
Singapore·CLASS C·Gendex Dental Systems·Registered October 22, 2012Device 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 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. VixWin™ 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.
Product Owner
- Short Name
- Gendex Dental System
- Address
- 1910 North Penn Road, Hatfield, Pennsylvania, 19440, UNITED STATES
Registrant
- Name
- EHC SUPPLY
- Address
- 7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
- Name
- EHC SUPPLY
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C