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® COV OC43 PRIMERS (ASR) Ref COV OC43 PRIMERS (ASR)
BioZorb F0221 Ref F0221
Aptima® KIT, CONTROLS, HBV, VL, US IVD Ref KIT, CONTROLS, HBV, VL, US IVD
Aptima® CMV, CALIBRATOR KIT, APTIMA, IVD Ref CMV, CALIBRATOR KIT, APTIMA, IVD
ThinPrep 5000 Processor TP-5000 Accessory Kit Ref TP-5000 Accessory Kit
Accuprobe® Kit, Accuprobe, M. Tuberculosis Ref KIT,ACCUPROBE,M. TUBERCULOSIS
MammoPad Radiolucent Cushion MP201-10 Ref MP201-10
Discovey C Discovery C Ref Discovery C
Atec Mme-00345 Ref MME-00345
Selenia® Dimensions® ASY-04160-HTC Ref ASY-04160-HTC
Discovery SL Ref Discovery SL
Procleix Ultrio Plus 5K Ref Ultrio Plus 5K
BioZorb F0203 Ref F0203
Panther Fusion® LBLD, VZV PLASMID (UNASSAYED CONTROL) Ref LBLD, VZV PLASMID (UNASSAYED CONTROL)
Affirm Breast Biopsy Guidance System ASY-03668 Ref ASY-03668
Aptima® KIT, BX 2 (RT) M GEN, 100T, AS, IVD Ref KIT, BX 2 (RT) M GEN, 100T, AS, IVD
Selenia FFDM ASY-06755 Ref ASY-06755
SecurMark SMARK-EVIVA-2S-13 Ref SMARK-EVIVA-2S-13
Atec Pearl Ref ATEC PEARL
Selenia FFDM ASY-01427 Ref ASY-01427
Procleix Ultrio 1K Ref Ultrio 1K
Sertera Biopsy Device Sertera-14 Ref Sertera-14
TruNode Surgical Gamma Probe 120-807605 Ref 120-807605
Hologic UNIVERSAL ARM4/RED FRET Ref UNIVERSAL ARM4/RED FRET
SecurMark SMARK-E13-SS3 Ref SMARK-E13-SS3
4.0-5.0 Cm Ct Lumen Marker Set B90003 Ref B90003
Aptima KIT, APTIMA, HIV-1&HCVQL15 TO30C IVD BOX 3 Ref KIT,APTIMA,HIV-1&HCVQL15 TO30C IVD BOX 3
ThinPrep Imaging System Server Ref ThinPrep Imaging System Server
Selenia® Dimensions® ASY-04160-CN Ref ASY-04160-CN
SecurMark for ATEC SMARK-ATEC-2S-13-09 Ref SMARK-ATEC-2S-13-09
3Dimensions™ ASY-10559-BR Ref ASY-10559-BR
Panther Fusion® COV OC43 PROBE (ASR) Ref COV OC43 PROBE (ASR)
Aptima® KIT, ATV (RT), IVD 100 Ref KIT, ATV (RT), IVD 100
Digital Diagnostics System Information Management System, Large Ref INFORMATION MANAGEMENT SYSTEM, LARGE
Eviva Needle Guide EVIVA_NG12L Ref EVIVA_NG12L
Atec Sapphire Ref ATEC SAPPHIRE
Panther® PANTHER, INSTRUMENT SYSTEM Ref PANTHER, INSTRUMENT SYSTEM
ThinPrep ACCESSORY KIT, THINPREP GENESIS Ref ACCESSORY KIT, THINPREP GENESIS
Aptima® KIT, CALIBRATOR, HCV QUANT, US IVD Ref KIT, CALIBRATOR, HCV QUANT, US IVD
Selenia Dimensions ASY-01994 Ref ASY-01994
Atec Mme-01782 Ref MME-01782
Aptima® APTIMA AUTO DETECT KIT (CE) Ref APTIMA AUTO DETECT KIT (CE)
Aptima® APTIMA URINE SPECIMEN COLLECTION KIT Ref APTIMA URINE SPECIMEN COLLECTION KIT
Hologic UNIVERSAL ARM1/RED FRET Ref UNIVERSAL ARM1/RED FRET
Progensa PSA Ref PSA
NovaSure NS2013US Ref NS2013US
Selenia FFDM FAB-00610 Ref FAB-00610
Showing 101-150 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