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Infinitt Xelis Dental 2.0 - HSA Registration DE0509434

Access comprehensive regulatory information for Infinitt Xelis Dental 2.0 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509434 and owned by Infinitt Healthcare Co. Ltd. The device was registered on June 21, 2024.

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 B
DE0509434
Infinitt Xelis Dental 2.0
HSA Registration Number: DE0509434
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Product Description

Xelis Dental 2.0 is a standard PC based software application used for the display and 3d visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0 is intended to be used by authorized healthcare professionals such as radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0 also provides 3d visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the simulation and evaluation of dental implants.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509434
Registration Date
June 21, 2024
Retention Due Date
June 20, 2025
Product Owner
Short Name
Infinitt
Address
12F Daerung Post Tower III 182-4, Guro-dong, Guro-Gu, Seoul, Korea 152-050, KOREA, REPUBLIC OF
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
Xelis Dental 2.0
Model Identifier(s)
2