Hologic
United States US-MF-000001646 Last updated 23 Oct 2026
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- Devices
- 864
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
SecurMark MRI SMARK-M-SS2 Ref SMARK-M-SS2
Selenia Dimensions ASY-05469 Ref ASY-05469
Atec Sapphire 100 Ref ATEC SAPPHIRE 100
Selenia Dimensions 3D System 3D software Ref 3D software
Procleix Ultrio Plus 1K Ref Ultrio Plus 1K
Aptima® APTIMA SWAB SPECIMEN COLLECTION KIT Ref APTIMA SWAB SPECIMEN COLLECTION KIT
3DQUORUM Software Ref 3DQUORUM SOFTWARE
Atec Emerald Ref ATEC EMERALD
Procleix Ultrio Plus, HIV-1 D-Probes Ref Ultrio Plus, HIV-1 D-Probes
Procleix Ultrio Plus Negative Calibrators Ref Ultrio Plus Negative Calibrators
Trimark Td 3612 Ref TRIMARK TD 3612
Selenia Dimensions ASY-08483 Ref ASY-08483
Procleix System Fluid Preservative Ref Procleix System Fluid Preservative
Selenia Dimensions ASY-08482 Ref ASY-08482
Procleix Ultrio Plus HBV D-Probes Ref Ultrio Plus HBV D-Probes
Selenia FFDM 3-000-4617 Ref 3-000-4617
Selenia FFDM 3-535-0012 Ref 3-535-0012
Third Wave Universal ARM1/Fam Fret Ref UNIVERSAL ARM1/FAM FRET
Accuprobe, B. Dermatitidis Ref ACCUPROBE, B. DERMATITIDIS
CoolSeal™ Mini CSL-MN103-20 Ref CSL-MN103-20
SecurMark for ATEC SMARK-ATEC-2S-36-12 Ref SMARK-ATEC-2S-36-12
Selenia FFDM ASY-06758 Ref ASY-06758
Myosure Xl Hysteroscopy Set 50-250XL Ref 50-250XL
BioZorb F0303 Ref F0303
ThinPrep 5000 Processor TP-5000 Autoloader Accessory Kit Ref TP-5000 Autoloader Accessory Kit
Selenia FFDM ASY-00834 Ref ASY-00834
Selenia Dimensions ASY-01966 Ref ASY-01966
Faxitron Core Corevision 5X10 Ref COREVISION 5X10
Celeromark-2S Ref CELEROMARK-2S
ThinPrep Pap Test Physician Kit Ref ThinPrep Pap Test Physician Kit
Selenia Dimensions ASY-01986 Ref ASY-01986
Selenia FFDM ASY-07973 Ref ASY-07973
Trimark-Eviva-2S-10 Ref TRIMARK-EVIVA-2S-10
Eviva Needle Guide EVIVA_NG09R Ref EVIVA_NG09R
Procleix Ultrio 1K Ref Ultrio 1K
Selenia Dimensions SDM-SYS-6000-3D Ref SDM-SYS-6000-3D
Faxitron Path 2050-0104 Ref 2050-0104
TriMark TRIMARKTD-2S-13-MR Ref TRIMARKTD-2S-13-MR
Procleix Ultrio Negative Calibrators Ref Ultrio Negative Calibrators
BioZorb F0404 Ref F0404
Fluent Pro Fluid Management System Procedure Kit Ref FLT-212S
Aptima HPV Assay Calibrators Kit Ref 302554
Panther Fusion AdV/hMPV/RV Assay Controls Kit Ref PRD-04338
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device Ref EVIVA_0910-12T
ATEC MRI Breast Biopsy and Excision System Handpiece Ref ATEC 0914-12MR
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device Ref EVIVA_0910-20
ATEC Breast Biopsy and Excision System Handpiece Ref ATEC 0912-12
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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