Hologic
United States US-MF-000001646 Last updated 23 Oct 2026
- Devices
- 864
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
6mm Operative Sheath 60-203 Ref 60-203
Procleix Ultrio Plus HCV D-Probes Ref Ultrio Plus HCV D-Probes
Discovery A Ref Discovery A
Trident Hd Specimen Radiography Tri-00002 Ref TRI-00002
Hologic UNIVERSAL ARM3/RED FRET Ref UNIVERSAL ARM3/RED FRET
MyoSure Tissue Removal Device 10-401 Ref 10-401
Non Gyn Only ThinPrep Genesis Processor Ref Non Gyn Only ThinPrep Genesis Processor
Selenia Dimensions ASY-02163 Ref ASY-02163
Procleix LBL BOX, DPROBE, ULTRIO, 200T, IVD Ref LBL BOX, DPROBE, ULTRIO, 200T, IVD
Aptima Panther, Trich Roomtemp, V2, 250T, Readymade Ref PANTHER,TRICH ROOMTEMP,V2,250T,READYMADE
MammoPad Radiolucent Cushion MP301 Ref MP301
Selenia Dimensions ASY-01950 Ref ASY-01950
ThinPrep Ref ThinPrep® Non-gynecological Microscope Slides
TriMark TRIMARKTD-2S-13-09 Ref TRIMARKTD-2S-13-09
Rapid fFN FFN SPECIMEN COLLECTION KIT, 25PK Ref FFN SPECIMEN COLLECTION KIT, 25PK
Brevera Breast Biopsy System BREVSTXKITG Ref BREVSTXKITG
Procleix Ultrio 1K Ref Ultrio 1K
Procleix Ultrio Plus 5K Ref Ultrio Plus 5K
SecurMark SMARK-EVIVA-2S-10 Ref SMARK-EVIVA-2S-10
Multiview Ref MultiView
Selenia FFDM ASY-05468 Ref ASY-05468
Procleix Oil Ref Procleix Oil
Aptima® BV CALIBRATOR, APTIMA, 100T, IVD Ref BV CALIBRATOR, APTIMA, 100T, IVD
Digital Diagnostics System Assembly, Review Station Computer Ref ASSEMBLY, REVIEW STATION COMPUTER
Celeromark Ref CELEROMARK
Group A Streptococcus Group A Strep Direct Test (Gasd) 500T Ref GROUP A STREP DIRECT TEST (GASD) 500T
Thinprep Imaging System Computer Ref Thinprep Imaging System Computer
Celero-12 Ref CELERO-12
Eviva_STX_KIT_GELAT Ref Eviva_STX_KIT_GELAT
Selenia FFDM 3-000-1528 Ref 3-000-1528
Selenia® Dimensions® ASY-10775-CN Ref ASY-10775-CN
Panther Fusion® COV NL63 PRIMERS (ASR) Ref COV NL63 PRIMERS (ASR)
Prodesse Proflu+ Assay Kit, 2, 000 Reactions Ref PROFLU+ ASSAY KIT, 2,000 REACTIONS
Accuprobe® Kit, Accuprobe, M. Avium Ref KIT, ACCUPROBE,M. AVIUM
Panther Fusion® OIL REAGENT Ref OIL REAGENT
ThinPrep Imaging System Workstation Ref ThinPrep Imaging System Workstation
Prodesse Pro Hmpv+ Kit, 100 Reactions Ref PRO HMPV+ KIT, 100 REACTIONS
Aptima® APTIMA GPRS, 250 TESTS (RT) Ref APTIMA GPRS, 250 TESTS (RT)
Eviva_STX_KIT_GEVER Ref Eviva_STX_KIT_GEVER
SecurMark for ATEC SMARK-ATEC-13-09 Ref SMARK-ATEC-13-09
Discovery W Ref Discovery W
Aptima Combo 2® KIT, BX 1 (REFRIG) AC2, 100T, AS, IVD Ref KIT, BX 1 (REFRIG) AC2, 100T, AS, IVD
Panther Fusion® COV 229E PRIMERS (ASR) Ref COV 229E PRIMERS (ASR)
Aptima® Ref KIT, BOX 2, ROOM TEMPERATURE, ACV/TV, 250T, IVD
Omni Hysteroscopy Light Set 60-250-2 Ref 60-250-2
Trimark Td 1309 Ref TRIMARK TD 1309
ThinPrep® UroCyte® Filters, 100pk Ref ThinPrep® UroCyte® Filters, 100pk
Accuprobe® Kit, Accuprobe, M.intracellulare Ref KIT,ACCUPROBE,M.INTRACELLULARE
Procleix Ultrio Calibrators Ref Ultrio Calibrators
Affirm Prone Biopsy System ASY-08832 Ref ASY-08832
Showing 551-600 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