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GE Senographe Crystal - HSA Registration DE0015883

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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CLASS C
DE0015883
GE Senographe Crystal
HSA Registration Number: DE0015883
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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.

Device 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 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