Singapore HSA registration DE0009150
Hologic Biopsy Site Markers (Titanium)
Singapore·CLASS C·Hologic, Inc·Registered May 04, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
- HSA Product Code
- HSAMDC00112
- HS Code
- 90189090
Registration information
- Registration Number
- DE0009150
- Registration Date
- May 04, 2012
- Change Notification Approval Date
- December 06, 2023
- Retention Due Date
- May 03, 2026
Product description
The biopsy site marker is indicated to mark an open or percutaneous biopsy site to radiographically mark the location of the biopsy site.
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)
- Biopsy Site Identifier for use with Celero-12 biopsy device Biopsy Site Identifier for use with Celero-12 biopsy device (2nd shape titanium site marker) Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle (MR modality) Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle (2nd shape titanium site marker) Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle (2nd shape titanium site marker) Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle (2nd shape titanium site marker; MR modality) Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle (2nd shape titanium site marker) Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle (2nd shape titanium site marker) Biopsy Site Identifier for use with Eviva (for use with 10 centimeter biopsy needle) Biopsy Site Identifier for use with Eviva (for use with 13 centimeter biopsy needle) Biopsy Site Identifier for use with Eviva (for use with 13 centimeter biopsy needle; 2nd shape titanium site marker) Biopsy Site Identifier for use with ATEC 9-gauge biopsy needle Biopsy Site Identifier for use with ATEC 12-gauge biopsy needle Biopsy Site Identifier for use with Eviva (for use with 10 centimeter biopsy needle; 2nd shape titanium site marker)
- Model Identifier(s)
- CeleroMark (10 ct) CeleroMark-2S (10 ct) TriMark TD 13MR (10 ct) TriMark TD 36-09 (10 ct) TriMark TD 36-12 (10 ct) TriMark TD-2S-13-09 (10 ct) TriMark TD-2S-13-12 (10 ct) TriMark TD-2S-13-MR (10ct) TriMark TD-2S-36-09 (10 ct) TriMark TD-2S-36-12 (10 ct) TriMark-Eviva-10 (10 ct) TriMark-Eviva-13 (10 ct) TriMark-Eviva-2S-13 (10 ct) TriMarkTD 13-09 (10 ct) TriMarkTD 13-12 (10 ct) Trimark-Eviva-2S-10 (10 ct)
About this record
Access comprehensive regulatory information for Hologic Biopsy Site Markers (Titanium) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0009150 and owned by Hologic, Inc. The device was registered on May 04, 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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