Singapore HSA registration DE0506758
Vatech Smart Plus Computed Tomography X-ray System
Singapore·CLASS C·Vatech Co., Ltd·Registered March 29, 2022Device 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 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.
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
- 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)
About this record
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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