Singapore HSA registration DE0015883
GE Senographe Crystal
Singapore·CLASS C·GE Ultrasound Korea, Ltd·Registered July 08, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90221400
Registration information
- Registration Number
- DE0015883
- Registration Date
- July 08, 2014
- Change Notification Approval Date
- August 12, 2015
- Retention Due Date
- July 07, 2025
Product description
The Senographe Crystal is a Digital mammographic X-ray system to be used only for breast examination under control of expert and qualified personnel in dedicated medical sites like hospitals and/or equivalent.
Product Owner
- Short Name
- GE Ultrasound Korea, Ltd
- Address
- 9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- Senographe Cystal - SFOV System Senographe Cystal - LFOV System Magnification kit Radiation Screen (Lead glass)
- Model Identifier(s)
- S30332AE S30332AF S30332DA S30332DB
About this record
Access comprehensive regulatory information for GE Senographe Crystal in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0015883 and owned by GE Ultrasound Korea, Ltd. The device was registered on July 08, 2014.
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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