Hologic
United States US-MF-000001646 Last updated 23 Oct 2026
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- Devices
- 864
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
ThinPrep® Stain Rinse II Solution, 4 L Ref ThinPrep® Stain Rinse II Solution, 4 L
Procleix Ultrio 5K Ref Ultrio 5K
SecurMark for ATEC SMARK-A1312-SS1 Ref SMARK-A1312-SS1
ThinPrep Imaging System Workstation Ref ThinPrep Imaging System Workstation
Progensa PSA Ref PSA
Prodesse Proflu+ Assay Ref PRODESSE PROFLU+ ASSAY
Horizon W Ref Horizon W
30 Degree 6mm operative sheath 60-203-30 Ref 60-203-30
Eviva_STX_KIT_SLOC Ref Eviva_STX_KIT_SLOC
ThinPrep® Ref ThinPrep® CytoLyt® Sol'n 30-mL tube, Int'l
Aptima® KIT, ATV-V2, ROOM TEMP, 100T Ref KIT, ATV-V2, ROOM TEMP, 100T
ThinPrep® UroCyte® Microscope Slides Ref ThinPrep® UroCyte® Microscope Slides
Aptima® CV/TV CONTROLS, APTIMA, 100T, IVD Ref CV/TV CONTROLS, APTIMA, 100T, IVD
ATEC Canister Ref ATEC Canister
Aptima® KIT, BX 1 (REF) M GEN, 100T, AS, IVD Ref KIT, BX 1 (REF) M GEN, 100T, AS, IVD
Procleix Ultrio Plus TIGRIS Controls Ref Ultrio Plus TIGRIS Controls
Selenia Dimensions ASY-07460 Ref ASY-07460
ThinPrep 5000 Processor Ref ThinPrep 5000 Processor
Aptima® KIT, MGEN, CONTROLS, AS, IVD Ref KIT, MGEN, CONTROLS, AS, IVD
Selenia FFDM ASY-00676 Ref ASY-00676
3Dimensions 3DM-SYS-INTL3D Ref 3DM-SYS-INTL3D
Selenia FFDM 4-000-0293 Ref 4-000-0293
ThinPrep Imaging System Workstation Ref ThinPrep Imaging System Workstation
Prodesse Profast+ Kit, 100 Reactions Ref PROFAST+ KIT, 100 REACTIONS
Panther Fusion® DNA CMV Primers (ASR) Ref DNA CMV Primers (ASR)
Cenova Server Ref Cenova Server
3Dimensions™ ASY-10559-V2.1 Ref ASY-10559-V2.1
I-View 2.0 Software Ref I-View 2.0 Software
ThinPrep Imaging System Workstation Ref ThinPrep Imaging System Workstation
ThinPrep 2000 Processor Ref ThinPrep 2000 Processor
Omni Hysteroscopy Standard Set 60-250-1 Ref 60-250-1
Affirm Prone Biopsy System System Software Ref System Software
Omni-S-001 Ref OMNI-S-001
Selenia Dimensions SDM-SYS-9000-2D Ref SDM-SYS-9000-2D
Panther Fusion® FLU A B RSV CTRLS, PANTHER FUSION, IVD Ref FLU A B RSV CTRLS, PANTHER FUSION, IVD
Third Wave Universal General Purpose Reagents Ref UNIVERSAL GENERAL PURPOSE REAGENTS
Aptima® Kit, Calibrators, Hiv Quant, Us Ivd Ref KIT, CALIBRATORS, HIV QUANT, US IVD
Procleix Ultrio TIGRIS Controls Mag 3.3 Ref Ultrio TIGRIS Controls Mag 3.3
Omni Hysteroscope 60-200 Ref 60-200
Hologic RNA, NG RES PROBE (ASR) Ref RNA, NG RES PROBE (ASR)
Affirm Prone Biopsy System ASY-08174 Ref ASY-08174
Flourocsan InSight InSight FD Refresh Ref InSight FD Refresh
BioZorb F0231 Ref F0231
Aptima® Kit, Controls, Hiv Quant, Us Ivd Ref KIT, CONTROLS, HIV QUANT, US IVD
Aptima KIT, APTIMA CT ASSAY FLUIDS Ref KIT,APTIMA CT ASSAY FLUIDS
Prodesse Proparaflu+ Kit, 100 Reactions Ref PROPARAFLU+ KIT, 100 REACTIONS
Aptima® KIT, BX 1 (REF) ACT, 100T, AS, IVD Ref KIT, BX 1 (REF) ACT, 100T, AS, IVD
Panther Fusion® RNA, IC Probe (ASR) Ref RNA, IC Probe (ASR)
Cervista Manual System Computer Ref Cervista Manual System Computer
Showing 301-350 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