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Singapore HSA registration DE0506759

Vatech Green Computed Tomography X-ray System

Singapore flagSingapore·CLASS C·Vatech Co., Ltd·Registered March 29, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506759
Registration Date
March 29, 2022
Retention Due Date
March 28, 2026
Product description
Green is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT (for Green 16, 18 and 21 only), sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
Product Owner
Name
Vatech Co., Ltd
Short Name
Vatech Co., Ltd
Address
13, Samsung 1-ro 2-gil,, Hwaseong-si, Gyeonggi-do, 18449, KOREA, REPUBLIC OF
Registrant
Name
QST TECHNOLOGIES PTE. LTD.
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
Name
QST DENTAL PTE. LTD. QST TECHNOLOGIES PTE. LTD.
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model information
Model Name(s)
EZ3D-i EzDent-i Computed Tomography X-ray System Computed Tomography X-ray System Computed Tomography X-ray System Computed Tomography X-ray System Computed Tomography X-ray System Computed Tomography X-ray System
Model Identifier(s)
EZ3D-i EzDent-i Green 16 (PHT-65LHS,SC) Green 16 (PHT-65LHS,SP) Green 18 (PHT-65LHS,SC) Green 18 (PHT-65LHS,SP) Green 21 (PCT-90LH) Green X (PHT-75CHS)
About this record

Access comprehensive regulatory information for Vatech Green Computed Tomography 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 DE0506759 and owned by Vatech Co., Ltd. The device was registered on March 29, 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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