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Hologic Affirm Prone Biopsy System - HSA Registration DE0505143

Access comprehensive regulatory information for Hologic Affirm Prone Biopsy System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505143 and owned by Hologic Inc.. The device was registered on November 13, 2020.

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
DE0505143
Hologic Affirm Prone Biopsy System
HSA Registration Number: DE0505143
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Product Description

The Affirm prone biopsy system is intended for lesion location for biopsy while the patient is in the prone position to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0505143
Registration Date
November 13, 2020
Change Notification Approval Date
December 12, 2024
Retention Due Date
November 12, 2025
Product Owner
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
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model Information
Model Name(s)
AFFIRM PRONE BIOPSY SYSTEM - GENERATOR AFFIRM PRONE BIOPSY SYSTEM - AXL PADDLE AFFIRM PRONE BIOPSY SYSTEM - STD BIOPSY PADDLE AFFIRM PRONE BIOPSY SYSTEM - STD BIOPSY PADDLE AFFIRM PRONE BIOPSY SYSTEM - LTRL BIOPSY PADDLE Acquisition Workstation Affirm Prone Biopsy System - Gantry 2D™ CONFIGURATION, AFFIRM PRONE BIOPSY SYSTEM 3D™ CONFIGURATION, AFFIRM PRONE BIOPSY SYSTEM AFFIRM PRONE BIOPSY 3D UPGRADE
Model Identifier(s)
ASY-06886 ASY-08174 ASY-08175 ASY-08176 ASY-08178 ASY-08832 ASY-09175 PBX-SYS-AFFIRM-2D PBX-SYS-AFFIRM-3D PBX-UP-AFFIRM-3D