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de Götzen X-MIND Unity - HSA Registration DE0500933

Access comprehensive regulatory information for de Götzen X-MIND Unity in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0500933 and owned by de Götzen S.r.l.. The device was registered on December 01, 2017.

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
DE0500933
de Götzen X-MIND Unity
HSA Registration Number: DE0500933
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Product Description

The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. From a clinical application point of view, the X-MIND unity can be applied in routine, dental radiography examinations involving the diagnosis, treatment, i.e. surgical or interventional, of diseases of the teeth, jaws and oral cavity structures. Its intended medical indication are: • generic dentistry; • dental implantology; • dental surgery.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0500933
Registration Date
December 01, 2017
Retention Due Date
November 30, 2025
Product Owner
Short Name
de Götzen S.r.l.
Address
Via Roma, 45, 21057 Olgiate Olona (VA), Italy, ITALY
Registrant
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Importer
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model Information
Model Name(s)
SOPIX®² INSIDE SENSOR SIZE 1 - HIGH DEFINITION for Windows® SOPIX®² INSIDE SENSOR SIZE 2 - HIGH DEFINITION for Windows® SOPIX®² INSIDE SENSOR SIZE 1 - HIGH DEFINITION for Mac® SOPIX®² INSIDE SENSOR SIZE 2 - HIGH DEFINITION for Mac® SOPIX® INSIDE SENSOR SIZE 1 - STANDARD DEFINITION for Windows® SOPIX® INSIDE SENSOR SIZE 2 - STANDARD DEFINITION for Windows® SOPIX® INSIDE SENSOR SIZE 1 - STANDARD DEFINITION for Mac® SOPIX® INSIDE SENSOR SIZE 2 - STANDARD DEFINITION for Mac® X - MIND unity TOP 40 SHORT CONE X - MIND unity TOP 80 SHORT CONE X - MIND unity TOP 110 SHORT CONE X - MIND unity TOP 40 LONG CONE X - MIND unity TOP 80 LONG CONE X - MIND unity TOP 110 LONG CONE X - MIND unity TOP 40 LONG SQUARE CONE X - MIND unity TOP 80 LONG SQUARE CONE X - MIND unity TOP 110 LONG SQUARE CONE X - MIND unity BOTTOM 40 SHORT CONE X - MIND unity BOTTOM 80 SHORT CONE X - MIND unity BOTTOM 110 SHORT CONE X - MIND unity BOTTOM 40 LONG CONE X - MIND unity BOTTOM 80 LONG CONE X - MIND unity BOTTOM 110 LONG CONE X - MIND unity BOTTOM 40 LONG SQUARE CONE X - MIND unity BOTTOM 80 LONG SQUARE CONE X - MIND unity BOTTOM 110 LONG SQUARE CONE X - MIND unity short cone X - MIND unity long cone X-MIND unity square cone Mind™ unity unity tubehead X-MIND unity timer Extensor 0.40 m X-MIND unity top mounting Extensor 0.80 m X-MIND unity top mounting Extensor 1.10 m X-MIND unity top mounting Extensor 0.40 m X-MIND unity bottom mounting Extensor 0.80 m X-MIND unity bottom mounting Extensor 1.10 m X-MIND unity bottom mounting Extensor pantograph X-MIND unity IRIX 70 wall plate for X-MIND unity installation F03899
Model Identifier(s)
S_802_5000 S_802_5001 S_802_5002 S_802_5003 S_802_6000 S_802_6001 S_802_6002 S_802_6003 W0800000 W0800001 W0800002 W0800003 W0800004 W0800005 W0800006 W0800007 W0800008 W0800009 W0800010 W0800011 W0800012 W0800013 W0800014 W0800015 W0800016 W0800017 W0800018 W0800019 W0800020 W0800022 W0800023 W0800025 W0800026 W0800027 W0800028 W0800029 W0800030 W0800031 W0800100