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Gendex eXpert DC - HSA Registration DE0016723

Access comprehensive regulatory information for Gendex eXpert DC in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016723 and owned by Gendex Dental Systems. The device was registered on January 05, 2015.

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
DE0016723
Gendex eXpert DC
HSA Registration Number: DE0016723
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Product Description

The Gendex Expert DC intraoral X-ray device is an extraoral source of X-rays intended for dental radiographic examinations and diagnosis of disease of teeth, jaw, and oral structures in general by trained professionals

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221300
Registration Information
Registration Number
DE0016723
Registration Date
January 05, 2015
Retention Due Date
January 04, 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
Model Information
Model Name(s)
Expert DC Coil-Cord Exposure Switch Gendex Expert DC Master Control Touch Panel Tube Head 21 cm/ 36 x 46 mm Rectangular Beam Limiting Device 8 inch/30cm Beam Limiting Device 12 inch/30cm Beam Limiting Device 30 cm/ 36 x 46 mm Rectangular Beam Limiting Device Horizontal Arm 34 inch Horizontal Arm 24 inch Horizontal Arm 14 inch Articulated Arm Gendex Expert DC
Model Identifier(s)
0.820.0352 110-0205G1 110-0210G2 112-0950G1 112-0951G1 112-0952G1 112-1019G1 112-1192G1 112-1192G2 112-1192G3 112-1194G1 EXPERT DC