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Vatech Smart Plus Computed Tomography X-ray System - HSA Registration DE0506758

Access comprehensive regulatory information for Vatech Smart Plus 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 DE0506758 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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CLASS C
DE0506758
Vatech Smart Plus Computed Tomography X-ray System
HSA Registration Number: DE0506758
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Product Description

Smart Plus is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, 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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0506758
Registration Date
March 29, 2022
Retention Due Date
March 28, 2026
Product Owner
Short Name
Vatech Co., Ltd
Address
13, Samsung 1-ro 2-gil,, Hwaseong-si, Gyeonggi-do, 18449, KOREA, REPUBLIC OF
Registrant
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
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
Model Identifier(s)
EZ3D-i EzDent-i Smart Plus (PHT-35LHS)