Hologic
United States US-MF-000001646 Last updated 23 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 864
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
FAXITRON PATH PATHVISION 23x29 Ref PATHVISION 23x29
Brevera Breast Biopsy System BREVSTYLBRKT Ref BREVSTYLBRKT
Brevera Breast Biopsy System BREVDISP09 Ref BREVDISP09
NovaSure V5 Ref V5
Selenia® Dimensions® SDA-SYS-3000-2D-BR Ref SDA-SYS-3000-2D-BR
MyoSure Tissue Removal Device 50-401XL Ref 50-401XL
Accuprobe Reagents, 200 Tests Ref ACCUPROBE REAGENTS, 200 TESTS
30 Degree Omni Hysteroscope XL Outflow Channel 50-201XL-30 Ref 50-201XL-30
Aptima® KIT, ATV-V2, REFIGERATED, 250T Ref KIT, ATV-V2, REFIGERATED, 250T
Panther Fusion® DNA CMV PROBE (ASR) Ref DNA CMV PROBE (ASR)
Selenia Dimensions ASY-02037 Ref ASY-02037
Acessa ProVu System MS-06-0171 Ref MS-06-0171
MammoPad Radiolucent Cushion MP301-D Ref MP301-D
ThinPrep UroCyte Vial Ref UroCyte Vial
Procleix Ultrio 5K Ref Ultrio 5K
Invader Hologic Dna Extraction Kit - Domestic Ref HOLOGIC DNA EXTRACTION KIT - DOMESTIC
Panther Fusion® RNA, IC Primers (ASR) Ref RNA, IC Primers (ASR)
ThinPrep Imaging System Workstation Ref ThinPrep Imaging System Workstation
Procleix Ultrio Plus 1K Ref Ultrio Plus 1K
Aptima® KIT, APTIMA HPV 16 18/45, CALS IVD Ref KIT, APTIMA HPV 16 18/45, CALS IVD
Aptima® KIT, CALIBRATOR, HBV VL, US IVD Ref KIT, CALIBRATOR, HBV VL, US IVD
Selenia Dimensions ASY-06202 Ref ASY-06202
Digital Spot Mammography System, DSM 3-000-2247 Ref 3-000-2247
Aptima® Ref KIT SPECIMEN DILUENT VIRL LOAD ASY APTIMA US IVD
Procleix Buffer for Deactivation Fluid Ref Procleix Buffer for Deactivation Fluid
ThinPrep Imaging System Ref ThinPrep® Imaging System Microscope Slides, 100pk
Eviva Needle Guide EVIVA_NG09L Ref EVIVA_NG09L
5.5mm Operative Sheath 60-202 Ref 60-202
BioZorb F0202 Ref F0202
Aptima® APTIMA GC ASSAY SPECIFIC REAGENTS Ref APTIMA GC ASSAY SPECIFIC REAGENTS
Aptima Combo 2® KIT, APT. COMBO 2 (ROOM TEMP)CE Ref KIT,APT. COMBO 2 (ROOM TEMP)CE
3Dimensions™ ASY-11748-2D-V2.1 Ref ASY-11748-2D-V2.1
Panther Fusion® RECON-1 KIT, PANTHER FUSION, 1920T, IVD Ref RECON-1 KIT, PANTHER FUSION, 1920T, IVD
Tomcat® TOMCAT SYSTEM Ref TOMCAT SYSTEM
Perl R10-5 Ref R10-5
Invader Factor V, 144 Tests Ref INVADER FACTOR V, 144 TESTS
Acessa ProVu System 7400 Ref 7400
I -View™ Contrast Enhanced Digital Mammography ASY-08109 Ref ASY-08109
Aptima® KIT, HPV, APTIMA, CONTROLS, IVD Ref KIT,HPV,APTIMA, CONTROLS, IVD
Accuprobe® Kit, Accuprobe, M. Gordonae Ref KIT, ACCUPROBE,M. GORDONAE
Selenia Dimensions ASY-02162 Ref ASY-02162
Aptima® CMV, TER, APTIMA, IVD Ref CMV, TER, APTIMA, IVD
Affirm Prone Biopsy System ASY-09175 Ref ASY-09175
MammoPad Radiolucent Cushion MP201 Ref MP201
Aptima® KIT, HPV, APTIMA, 250 TEST, REFRIG, IVD Ref KIT, HPV, APTIMA, 250 TEST, REFRIG, IVD
Selenia FFDM FAB-00754 Ref FAB-00754
3Dimensions 3DM-SYS-INTL3D-MOB Ref 3DM-SYS-INTL3D-MOB
Aptima® CV/TV CALIBRATOR, APTIMA, 100T, IVD Ref CV/TV CALIBRATOR, APTIMA, 100T, IVD
Showing 451-500 of 864
EUDAMED certificates
Notified body 2797 6 certificates
- IVDR 740190 Reissued
Quality management system EU IVDR
- Issued
- 27 Jul 2026
- Expires
- 11 Oct 2031
- Valid from
- 12 Oct 2026
- IVDR 779051 Issued
Technical documentation EU IVDR
- Issued
- 19 May 2026
- Expires
- 18 May 2031
- IVDR 779050 Amended
Technical documentation EU IVDR
- Issued
- 17 Nov 2025
- Expires
- 8 Sep 2030
- Reason
- Other
- IVDR 779052 Amended
Technical documentation EU IVDR
- Issued
- 17 Nov 2025
- Expires
- 8 Sep 2030
- Reason
- Other
- IVDR 751158 Supplemented
Quality management system EU IVDR
- Issued
- 23 Jun 2026
- Expires
- 6 Dec 2027
- Reason
- Add device or group
- MDR 743693 Supplemented
Quality management system EU MDR
- Issued
- 25 Sep 2026
- Expires
- 11 Oct 2027
- Reason
- Other
Related companies
Notified bodies
- Notified body 2797
What Hologic makes
Hologic manufactures the ATEC Breast Biopsy and Excision System Handpiece, a device used for minimally invasive breast biopsy and excision procedures to remove tissue samples or lesions for diagnostic evaluation.
This device is classified as Class IIa under EU regulations and is listed in the EUDAMED database. The company is based in the United States.
Frequently asked questions
What types of medical devices does Hologic manufacture?
Hologic specializes in devices for diagnostic and minimally invasive procedures. Specifically, they produce the ATEC Breast Biopsy and Excision System Handpiece, which is designed for breast biopsy and excision to remove tissue samples or lesions for further diagnostic evaluation. This device is tailored for procedures requiring precision and reduced invasiveness.
Where is Hologic based, and does it operate internationally?
Hologic is headquartered in the United States. While the company’s primary operations are based there, its devices are intended for global use, including regulatory listings in the EUDAMED database, which tracks medical devices authorized in the European Union.
How are Hologic’s devices classified under EU regulations?
Under EU medical device regulations, Hologic’s ATEC Breast Biopsy and Excision System Handpiece falls under Class IIa. This classification is determined by factors like the device’s intended use, potential risks, and the level of intervention it involves. Class IIa devices are considered moderate-risk and require compliance with specific safety and performance standards before authorization.
Which regulatory databases list Hologic’s devices?
Hologic’s ATEC Breast Biopsy and Excision System Handpiece is listed in the EUDAMED database, which is the official European Union registry for medical devices. Listing in EUDAMED confirms the device’s authorization status under EU regulations, ensuring transparency for healthcare providers and regulators.
Information
- Country
- United States
- Address
- 250 , Campus Drive, Marlborough, United States
- Website
- hologic.com
- [email protected]
- PRRC contact
- Marissa Richmond
- EUDAMED SRN
- US-MF-000001646
- FDA FEI number
- 2024800