Singapore HSA registration DE0009175
Hologic SecurMark® Biopsy Site Markers for ATEC®, Eviva® and Celero®
Singapore·CLASS D·Hologic, Inc·Registered May 22, 2012Device 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 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.
Product Owner
- Name
- Hologic, Inc
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D