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Singapore HSA registration DE0508687

Hologic Faxitron Trident HD Specimen Radiography System

Singapore flagSingapore·CLASS B·Hologic Inc.·Registered November 23, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0508687
Registration Date
November 23, 2023
Change Notification Approval Date
April 17, 2025
Retention Due Date
November 22, 2025
Product description
The Trident® specimen radiography system is a cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
Product Owner
Name
Hologic Inc.
Short Name
Hologic Inc.
Address
600 Technology Drive, Newark, DE 19702, UNITED STATES
Registrant
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model information
Model Name(s)
Faxitron Trident HD Specimen Radiography System
Model Identifier(s)
TRI-00002
About this record

Access comprehensive regulatory information for Hologic Faxitron Trident HD 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 DE0508687 and owned by Hologic Inc.. The device was registered on November 23, 2023.

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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