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Xoran MiniCAT Cone Beam CT Diagnostic Imaging Systems - HSA Registration DE0509458

Access comprehensive regulatory information for Xoran MiniCAT Cone Beam CT Diagnostic Imaging Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509458 and owned by Xoran Europe D.o.o. The device was registered on June 26, 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 C
DE0509458
Xoran MiniCAT Cone Beam CT Diagnostic Imaging Systems
HSA Registration Number: DE0509458
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Product Description

The MiniCAT is an X-ray imaging device that constructs a three-dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509458
Registration Date
June 26, 2024
Retention Due Date
June 25, 2025
Product Owner
Short Name
Xoran Europe D.o.o
Address
Mramorsko brdo bb, 18251 Meroลกina, SERBIA AND MONTENEGRO
Registrant
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
Address
3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model Information
Model Name(s)
MiniCAT IQ MiniCAT 2020
Model Identifier(s)
10012 10023