Hologic
United States US-MF-000001646 Last updated 23 Oct 2026
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- Devices
- 864
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Panther Fusion® INTERNAL CONTROL-B, 960T, IVD Ref INTERNAL CONTROL-B, 960T, IVD
MyoSure Rod Lens Hysteroscope 40-200 Ref 40-200
Aptima® KIT, AC2 SYS FL PRES, TIG, IVD-CE (302380) Ref KIT, AC2 SYS FL PRES,TIG,IVD-CE (302380)
Eviva_adapter_mtest Ref EVIVA_ADAPTER_MTEST
Aptima CLASS I CONTROL - L. CRISPATUS Ref CLASS I CONTROL - L. CRISPATUS
Selenia Dimensions ASY-04160 Ref ASY-04160
Selenia FFDM FAB-00752 Ref FAB-00752
Affirm Lateral Arm Upright Biopsy Accessory ASY-09644 Ref ASY-09644
Affirm Prone Biopsy System ASY-08175 Ref ASY-08175
ThinPrep® CytoLyt® Sol'n 30-mL tube Ref ThinPrep® CytoLyt® Sol'n 30-mL tube
Accuprobe, H. Capsulatum Ref ACCUPROBE, H. CAPSULATUM
Procleix Assay Fluids Ref Assay Fluids
Selenia Dimensions ASY-01940 Ref ASY-01940
Panther Fusion® BLOOD TRANSPORT MEDIUM Ref BLOOD TRANSPORT MEDIUM
Aptima® KIT, BOX 2, ROOM TEMP, ABV, 100T, IVD Ref KIT, BOX 2, ROOM TEMP, ABV, 100T, IVD
Dimensions CEDM Hardware Kit Ref CEDM Hardware Kit
Affirm Breast Biopsy Guidance System ASY-03669 Ref ASY-03669
Eviva_STX_KIT_GEL-V Ref Eviva_STX_KIT_GEL-V
MammoPad Radiolucent Cushion MP301-T Ref MP301-T
ThinPrep® Arcless Microscope Slides Ref ThinPrep® Arcless Microscope Slides
Affirm Breast Biopsy Guidance System STLC-00004 Ref STLC-00004
Hologic UNIVERSAL ARM4/FAM FRET Ref UNIVERSAL ARM4/FAM FRET
Aptima Combo 2® KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CE Ref KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CE
ThinPrep® PreservCyt® UroCyte® 30ml Kit Ref ThinPrep® PreservCyt® UroCyte® 30ml Kit
Eviva_stylet_bracket Ref EVIVA_STYLET_BRACKET
Celero Introducer CELERO INTRO-12 Ref CELERO INTRO-12
Aptima® KIT, RT, ATV, 250, CE Ref KIT, RT, ATV, 250, CE
Selenia® Dimensions® SDM-SYS-6000-2D-CN Ref SDM-SYS-6000-2D-CN
Panther Fusion® DNA BKV PRIMERS (ASR) Ref DNA BKV PRIMERS (ASR)
TLiIQ System Ref TLiIQ System
Selenia Dimensions ASY-02165 Ref ASY-02165
Affirm Prone Biopsy System PBX-SYS-AFFIRM-3D Ref PBX-SYS-AFFIRM-3D
Selenia Dimensions ASY-01993 Ref ASY-01993
Procleix Wash Solution Ref Procleix Wash Solution
Selenia Dimensions ASY-01946 Ref ASY-01946
Aptima® Ref APTIMA LIQUID PAP TRANSFER TUBES, IVD KIT
Aptima® KIT, BOX 2, ROOM TEMP, ABV, 250T, IVD Ref KIT, BOX 2, ROOM TEMP, ABV, 250T, IVD
Panther Fusion® LBLD, CMV PLASMID (UNASSAYED CONTROL) Ref LBLD, CMV PLASMID (UNASSAYED CONTROL)
Aptima Combo 2® KIT, APTIMACOMBO2, 100T, REF, CEIVD-UPDATED Ref KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATED
Aptima® BV CONTROLS, APTIMA, 100T, IVD Ref BV CONTROLS, APTIMA, 100T, IVD
Mammosite Multi-lumen Applicator Tray ML2345 Ref ML2345
Aptima® KIT, APTIMA HPV 16 18/45, 100 REF IVD Ref KIT, APTIMA HPV 16 18/45, 100 REF IVD
Selenia FFDM ASY-01656 Ref ASY-01656
Procleix West Nile Virus 5K Ref West Nile Virus 5K
Atec Stx-2 Ref ATEC STX-2
Invader Factor Ii, 1680 Tests Ref INVADER FACTOR II, 1680 TESTS
Panther Fusion® SPECIMEN LYSIS TUBES, IVD Ref SPECIMEN LYSIS TUBES, IVD
Selenia Dimensions ASY-03342 Ref ASY-03342
Definity Cervical Dilator, 5mm Dcd-501 Ref DCD-501
Selenia Dimensions ASY-08499 Ref ASY-08499
Showing 251-300 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