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Hologic SecurMark® Biopsy Site Markers for ATEC®, Eviva® and Celero® - HSA Registration DE0009175

Access comprehensive regulatory information for Hologic SecurMark® Biopsy Site Markers for ATEC®, Eviva® and Celero® in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0009175 and owned by Hologic, Inc. The device was registered on May 22, 2012.

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 D
DE0009175
Hologic SecurMark® Biopsy Site Markers for ATEC®, Eviva® and Celero®
HSA Registration Number: DE0009175
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Product Description

The SecurMark Biopsy Site Marker provides the user with the ability to mark the location of the cavity where a breast biopsy was performed. The SecurMark biopsy site marker is indicated for the permanent radiographic marking of sites in soft tissue.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDD00112
HS Code
90229090
Registration Information
Registration Number
DE0009175
Registration Date
May 22, 2012
Change Notification Approval Date
March 07, 2024
Retention Due Date
May 21, 2025
Product Owner
Short Name
Hologic, Inc
Address
250 Campus Drive, Marlborough, MA 01752, 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)
SecurMark Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle SecurMark Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle SecurMark Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle (2nd shape titanium site marker) SecurMark Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle (2nd shape titanium site marker) SecurMark Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle (2nd shape titanium site marker) SecurMark Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle (2nd shape titanium site marker) SecurMark Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle SecurMark Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle SecurMark Biopsy Site Identifier for use with Celero-12 biopsy device SecurMark Biopsy Site Identifier for use with Celero-12 biopsy device (2nd shape titanium site marker) SecurMark Biopsy Site Identifier for use with Eviva (for use with 10 centimeter biopsy needle) SecurMark Biopsy Site Identifier for use with Eviva (for use with 13 centimeter biopsy needle) SecurMark Biopsy Site Identifier for use with Eviva (for use with 10 centimeter biopsy needle; 2nd shape titanium site marker) SecurMark Biopsy Site Identifier for use with Eviva (for use with 13 centimeter biopsy needle; 2nd shape titanium site marker)
Model Identifier(s)
SMark-ATEC-13-09 SMark-ATEC-13-12 SMark-ATEC-2S-13-09 SMark-ATEC-2S-13-12 SMark-ATEC-2S-36-09 SMark-ATEC-2S-36-12 SMark-ATEC-36-09 SMark-ATEC-36-12 SMark-Celero SMark-Celero-2S SMark-Eviva-10 SMark-Eviva-13 SMark-Eviva-2S-10 SMark-Eviva-2S-13