Singapore HSA registration DE0014634
Hologic Faxitron Core Specimen Radiography System
Singapore·CLASS B·Hologic Inc.·Registered January 16, 2014Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0014634
- Registration Date
- January 16, 2014
- Change Notification Approval Date
- December 12, 2024
- Retention Due Date
- January 15, 2026
Product description
The CoreVision Digital Specimen Radiography (DSR) System is a compact desktop cabinet digital X-ray imaging system intended to provide rapid verification of core biopsies.
Product Owner
- Name
- Hologic Inc.
- Short Name
- Hologic Inc.
- Address
- 600 Technology Drive, Newark, DE 19702, UNITED STATES
Registrant
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
- Address
- 3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model information
- Model Name(s)
- Faxitron Core Tray (Pack of 25) Faxitron Core Digital Specimen Radiography System
- Model Identifier(s)
- 04-4126 COREVISION5X10
About this record
Access comprehensive regulatory information for Hologic Faxitron Core Specimen Radiography System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014634 and owned by Hologic Inc.. The device was registered on January 16, 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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