Singapore HSA registration DE0011651

Hologic ATEC Breast Biopsy and Excision System

Singapore·CLASS B·Hologic, Inc·Registered November 22, 2012

Device classification

Device Class: CLASS B
Medical Speciality Area: General Hospital
HSA Product Code: Refer to CRPNS
HS Code: 90181900

Registration information

Registration Number: DE0011651
Registration Date: November 22, 2012
Change Notification Approval Date: June 15, 2023
Retention Due Date: November 21, 2025

Product description

The ATEC Breast Biopsy and Excision System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC Breast Biopsy and Excision System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of the histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of the removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality e.g. malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

Product Owner

Name: Hologic, Inc
Short Name: Hologic, Inc
Address: 250 Campus Drive, Marlborough, MA 01752, 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): ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece ATEC Breast Biopsy and Excision System handpiece 400cc ATEC Suction Canister with Lid ATEC Breast Biopsy and Excision Needle Guide Aurora Needle Guide for use with ATEC MR handpiece and ILS (5 ct) Aurora Angled Needle Guide for use with ATEC MR handpiece and ILS. ATEC Breast Biopsy and Excision Needle Guide ATEC Breast Biopsy and Excision Needle Guide ATEC Breast Biopsy and Excision Needle Guide ATEC Remote Tissue Filter Adapter (5/case) Hologic ATEC Sapphire ATEC Breast Biopsy and Excision Adapter ATEC Breast Biopsy and Excision Adapter Hologic ATEC Sapphire Tissue Filter Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva Stereotactic Breast Biopsy System Biopsy Device Eviva adapter Eviva adapter Eviva adapter Introducer Localization System Introducer Localization System
Model Identifier(s): ATEC 0909-12 ATEC 0909-20 ATEC 0912-12 ATEC 0912-20 ATEC 0914-12MR ATEC 0914-20 ATEC 0914-20MR ATEC 1209-20 ATEC 1212-20 ATEC Canister ATEC NG09 ATEC NG09A1 ATEC NG09A2 ATEC NG09F ATEC NG12 ATEC NG12F ATEC RTFA ATEC SAPPHIRE25 ATEC STX-2 ATEC STX-2F ATEC Sapphire 200 ATEC TF-1 EVIVA 0910-12 EVIVA 0910-12T EVIVA 0910-20 EVIVA 0913-12 EVIVA 0913-12T EVIVA 0913-20 EVIVA 1210-20 EVIVA 1213-20 EVIVA_NG09L EVIVA_NG09R EVIVA_NG12L EVIVA_NG12R EVIVA_STX_KIT_13CM EVIVA_STX_KIT_GEL-V EVIVA_STX_KIT_MTEST ILS 0914-12 ILS 0914-20

About this record

Access comprehensive regulatory information for Hologic ATEC Breast Biopsy and Excision 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 DE0011651 and owned by Hologic, Inc. The device was registered on November 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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