EUDAMED update: Jun 12, 2026

Hologic, Inc.

US-MF-000045852

Active73 devices

Address: Campus Drive, 250 01752 Marlborough
Role: Manufacturer
Date of registration: Jan 6, 2025
Country: United States

Hologic, Inc. is a medical device manufacturer registered in EUDAMED. The company has 73 devices on the EU market across 31 countries. Headquartered in Marlborough, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Hologic, Inc. BRST Surgery

: US-MF-000045852
Role: Manufacturer
Country: United States
Organization name: Hologic, Inc.
EU VAT number: Not applicable
Trade register: 2219600
Date of registration: Jan 6, 2025

Contact details for Hologic, Inc. BRST Surgery

Email: rachelle.fitzgerald@hologic.com
Address: 250 , CAMPUS DRIVE 01752 MARLBOROUGH UNITED STATES

Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Officers and regulatory representatives of Hologic, Inc. BRST Surgery

RICHMOND Marissa
- the post-market surveillance obligations are complied with in accordance with Article 10(10) [MDR] - the reporting obligations referred to in Articles 87 to 91 [MDR] with regard to PMS reporting, are fulfilled;
Hidden
DELK Amy
EU MDR Article 15 Sub-section 3, (a) (b), (e)
Hidden

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
ATEC Breast Biopsy and Excision System Aurora Angled Needle Guide	ATEC Breast Biopsy and Excision System Aurora Angled Needle Guide	`ATEC_NG09-A2`	`05420045503154`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0909-12`	`15420045504837`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0909-20`	`15420045504844`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0914-20`	`15420045504882`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0912-12`	`15420045504851`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0912-20`	`15420045504868`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 1212-20`	`15420045504912`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 1209-20`	`15420045504905`	1	On the market
ATEC Breast Biopsy and Excision System Introducer Localization System	ATEC Breast Biopsy and Excision System Introducer Localization System	`ILS 0914-20`	`05420045503208`	1	On the market
ATEC Breast Biopsy and Excision System Introducer Localization System	ATEC Breast Biopsy and Excision System Introducer Localization System	`ILS 0914-12`	`05420045503192`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG12-LORAD`	`05420045503123`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG09-LORAD`	`05420045503109`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG09-FISCH`	`05420045503116`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG12-FISCH`	`05420045503130`	1	On the market
ATEC Breast Biopsy and Excision System Remote Tissue Filter Adapter	ATEC Breast Biopsy and Excision System Remote Tissue Filter Adapter	`ATEC RTFA`	`05420045503178`	1	On the market
ATEC Breast Biopsy and Excision System Tissue Filter	ATEC Breast Biopsy and Excision System Tissue Filter	`ATEC TF-1`	`05420045503161`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI090920`	`15420045504561`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI120920`	`15420045504585`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI121220`	`15420045504592`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI091220`	`15420045504578`	1	On the market
ATEC Canister	ATEC Canister	`ATEC Canister`	`15420045503182`	10	On the market
ATEC MRI Breast Biopsy and Excision System Handpiece	ATEC MRI Breast Biopsy and Excision System Handpiece	`ATEC 0914-20MR`	`15420045504899`	1	On the market
ATEC MRI Breast Biopsy and Excision System Handpiece	ATEC MRI Breast Biopsy and Excision System Handpiece	`ATEC 0914-12MR`	`15420045504875`	1	On the market
ATEC STX-2	ATEC STX-2	`ATEC STX-2`	`15420045509832`	1	On the market
ATEC TriMark Titanium Biopsy Site Marker	ATEC TriMark Titanium Biopsy Site Marker	`TRIMARKTD-2S-36-12`	`05420045503369`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
ATEC Breast Biopsy and Excision System Aurora Angled Needle Guide	ATEC Breast Biopsy and Excision System Aurora Angled Needle Guide	`ATEC_NG09-A2`	`05420045503154`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0909-12`	`15420045504837`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0909-20`	`15420045504844`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0914-20`	`15420045504882`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0912-12`	`15420045504851`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 0912-20`	`15420045504868`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 1212-20`	`15420045504912`	1	On the market
ATEC Breast Biopsy and Excision System Handpiece	ATEC Breast Biopsy and Excision System Handpiece	`ATEC 1209-20`	`15420045504905`	1	On the market
ATEC Breast Biopsy and Excision System Introducer Localization System	ATEC Breast Biopsy and Excision System Introducer Localization System	`ILS 0914-20`	`05420045503208`	1	On the market
ATEC Breast Biopsy and Excision System Introducer Localization System	ATEC Breast Biopsy and Excision System Introducer Localization System	`ILS 0914-12`	`05420045503192`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG12-LORAD`	`05420045503123`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG09-LORAD`	`05420045503109`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG09-FISCH`	`05420045503116`	1	On the market
ATEC Breast Biopsy and Excision System Needle Guide	ATEC Breast Biopsy and Excision System Needle Guide	`ATEC NG12-FISCH`	`05420045503130`	1	On the market
ATEC Breast Biopsy and Excision System Remote Tissue Filter Adapter	ATEC Breast Biopsy and Excision System Remote Tissue Filter Adapter	`ATEC RTFA`	`05420045503178`	1	On the market
ATEC Breast Biopsy and Excision System Tissue Filter	ATEC Breast Biopsy and Excision System Tissue Filter	`ATEC TF-1`	`05420045503161`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI090920`	`15420045504561`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI120920`	`15420045504585`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI121220`	`15420045504592`	1	On the market
ATEC Breast Biopsy and Excision System Ultrasound Introducer	ATEC Breast Biopsy and Excision System Ultrasound Introducer	`AI091220`	`15420045504578`	1	On the market
ATEC Canister	ATEC Canister	`ATEC Canister`	`15420045503182`	10	On the market
ATEC MRI Breast Biopsy and Excision System Handpiece	ATEC MRI Breast Biopsy and Excision System Handpiece	`ATEC 0914-20MR`	`15420045504899`	1	On the market
ATEC MRI Breast Biopsy and Excision System Handpiece	ATEC MRI Breast Biopsy and Excision System Handpiece	`ATEC 0914-12MR`	`15420045504875`	1	On the market
ATEC STX-2	ATEC STX-2	`ATEC STX-2`	`15420045509832`	1	On the market
ATEC TriMark Titanium Biopsy Site Marker	ATEC TriMark Titanium Biopsy Site Marker	`TRIMARKTD-2S-36-12`	`05420045503369`	1	On the market

Hologic, Inc.

About Hologic, Inc. BRST Surgery

Contact details for Hologic, Inc. BRST Surgery

Competent authority

Officers and regulatory representatives of Hologic, Inc. BRST Surgery

Related searches

About Hologic, Inc. BRST Surgery

Contact details for Hologic, Inc. BRST Surgery

Competent authority

Officers and regulatory representatives of Hologic, Inc. BRST Surgery

Approved members

Statistics for Hologic, Inc. BRST Surgery

Certificate health for Hologic, Inc. BRST Surgery

Related documents

Devices by risk class

Device catalog for Hologic, Inc. BRST Surgery

Device families (Basic UDI-DI) of Hologic, Inc. BRST Surgery

Market presence of Hologic, Inc. BRST Surgery

Connected operators

Importers

Authorised representatives

Related searches

Market presence of Hologic, Inc. BRST Surgery

Devices by risk class

Device families (Basic UDI-DI) of Hologic, Inc. BRST Surgery

Certificate health for Hologic, Inc. BRST Surgery

Statistics for Hologic, Inc. BRST Surgery

Approved members

Related documents

Connected operators

Importers

Authorised representatives

Device catalog for Hologic, Inc. BRST Surgery