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Gendex GXC-300โ„ข Intraoral Camera - HSA Registration DE0018894

Access comprehensive regulatory information for Gendex GXC-300โ„ข Intraoral Camera in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018894 and owned by Gendex Dental Systems. The device was registered on January 20, 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 B
DE0018894
Gendex GXC-300โ„ข Intraoral Camera
HSA Registration Number: DE0018894
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Product Description

This intra-oral camera system and accessories are indicated for used to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing results.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0018894
Registration Date
January 20, 2017
Retention Due Date
January 19, 2026
Product Owner
Short Name
Gendex Dental System
Address
1910 North Penn Road, Hatfield, Pennsylvania, 19440, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model Information
Model Name(s)
Gendex GXC-300โ„ข Intraoral Camera Set (w/o VixWin) Gendex GXC-300โ„ข Intraoral Camera Gendex GXC-300 Intraoral Camera Sheaths Gendex VixWinโ„ข Platinum Imaging Software
Model Identifier(s)
0.822.4331 1.007.1970 112-1348G1 VIXWINPL