HSA · registration DE0018894Gendex GXC-300™ Intraoral Camera
SingaporeDentalClass BGendex Dental Systems
Official record identity
- Registration number
- DE0018894
- Model name
- Gendex GXC-300™ Intraoral Camera Set (w/o VixWin); Gendex GXC-300™ Intraoral Camera; Gendex GXC-300 Intraoral Camera Sheaths; Gendex VixWin™ Platinum Imaging Software
- Model identifier
- 0.822.4331; 1.007.1970; 112-1348G1; VIXWINPL
- Registration date
- January 20, 2017
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Gendex Dental Systems
- Registrant / registration holder
- EHC SUPPLY
Official 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.
Additional source fields
- Product owner address
- 1910 North Penn Road, Hatfield, Pennsylvania, 19440, United States
- Registrant address
- 13 STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.