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Instrumentarium Dental Gendex GXIO-770 Intraoral X-ray - HSA Registration DE0018830

Access comprehensive regulatory information for Instrumentarium Dental Gendex GXIO-770 Intraoral X-ray in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018830 and owned by Instrumentarium Dental, PaloDEx Group Oy. The device was registered on December 22, 2016.

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
DE0018830
Instrumentarium Dental Gendex GXIO-770 Intraoral X-ray
HSA Registration Number: DE0018830
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Product Description

Gendex GXIO-770 is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0018830
Registration Date
December 22, 2016
Retention Due Date
December 21, 2025
Product Owner
Short Name
Instrumentarium Dental, PaloDEx Group Oy
Address
Nahkelantie 160, FI-04300 Tuusula, FINLAND
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
Short Reach (176cm/ 69") Medium Reach (190cm/ 75") Extra Long Reach (216cm/ 85") Long Cone Round Long Cone Rectangular Short Cone Round Short Cone Rectangular Long Full Metal Rectangular Cone Short Full Metal Rectangular Cone GXIO-770โ„ข Intraoral X-ray
Model Identifier(s)
214444 214447 214453 50410-IMG 50420-IMG 50540-IMG 50550-IMG 50720-IMG 50750-IMG 900972