Authorised Representative

Hologic BV

Belgium BE-AR-000000127 Active

Hologic BV is an authorised representative registered in EUDAMED under SRN BE-AR-000000127, based in Zaventem, Belgium. Its registry status is active. It acts for 1 manufacturer, all in United States. deviCERTS lists 120 active devices of these manufacturers.

Organization

Legal name: Hologic BV
Country: Belgium
SRN: BE-AR-000000127
VAT number: BE0445.434.787
PRRC contact: Marta Szczerczowska-Katillari

Contact

Registered address: Da Vincilaan
Zaventem
1930
Website: www.hologic.com
Email: ra.emea@hologic.com

Manufacturers represented1

Hologic, Inc.

US Authorised Representative

Where the companies are based1

United States 1

Country on record of each represented manufacturer.

Devices by registry and class120

By registry of the primary record

FDA 510(k): 102
FDA PMA: 18

By device class

Class II: 108
Class III: 9
Unclassified: 2
Class I: 1

Devices of these manufacturers120

Newest first, from the 500 most recent records of the represented manufacturers.

Panther Fusion Paraflu Assay

FDA 510(k) Class II Hologic, Inc.
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

FDA 510(k) Class II Hologic, Inc.
Genius AI Detection 2.0

FDA 510(k) Class II Hologic, Inc.
Aptima Neisseria gonorrhoeae Assay

FDA 510(k) Class II Hologic, Inc.
Genius AI Detection 2.0

FDA 510(k) Class II Hologic, Inc.
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

FDA 510(k) Class II Hologic, Inc.
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION

FDA 510(k) Class II Hologic, Inc.
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k) Class II Hologic, Inc.
Aptima Combo 2 Assay (Panther System)

FDA 510(k) Class II Hologic, Inc.
Panther Fusion GI Expanded Bacterial Assay

FDA 510(k) Class II Hologic, Inc.
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER

FDA 510(k) Class II Hologic, Inc.
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

FDA 510(k) Class II Hologic, Inc.
QDR-1000 AND WITH X-RAY BONE DENSITOMETER

FDA 510(k) Class II Hologic, Inc.
NHANES WHOLE BODY DXA REFERENCE DATABASE

FDA 510(k) Class II Hologic, Inc.
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

FDA 510(k) Class II Hologic, Inc.
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

FDA 510(k) Class II Hologic, Inc.
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k) Class II Hologic, Inc.
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

FDA 510(k) Class II Hologic, Inc.
MYOSURE INTRUMENT TRAY

FDA 510(k) Class II Hologic, Inc.
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001

FDA 510(k) Class II Hologic, Inc.
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k) Class II Hologic, Inc.
HOLOGIC DR IMAGEPRO

FDA 510(k) Class II Hologic, Inc.
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k) Class II Hologic, Inc.
DIGITAL SPOT MAMMOGRAPHY SYSTEM

FDA 510(k) Class II Hologic, Inc.
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

FDA 510(k) Class II Hologic, Inc.
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k) Class II Hologic, Inc.
Trident HD Specimen Radiography System

FDA 510(k) Class II Hologic, Inc.
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

FDA 510(k) Class II Hologic, Inc.
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

FDA 510(k) Class II Hologic, Inc.
MULTIVIEW

FDA 510(k) Class II Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

FDA 510(k) Class II Hologic, Inc.
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED

FDA 510(k) Class II Hologic, Inc.
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

FDA 510(k) Class II Hologic, Inc.
ProParaFlu+ Assay

FDA 510(k) Class II Hologic, Inc.
INVADER MTHFR 1298

FDA 510(k) Class II Hologic, Inc.
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS

FDA 510(k) Class II Hologic, Inc.
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER

FDA 510(k) Class II Hologic, Inc.
QUANTRA

FDA 510(k) Class II Hologic, Inc.
Sertera Biopsy Device

FDA 510(k) Class II Hologic, Inc.
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

FDA 510(k) Class II Hologic, Inc.
Aptima SARS-CoV-2 Assay

FDA 510(k) Class II Hologic, Inc.
Panther Fusion GI Bacterial Assay

FDA 510(k) Class II Hologic, Inc.
HOLOGIC VISCERAL FAT SOFTWARE

FDA 510(k) Class II Hologic, Inc.
Omni Instrument Tray

FDA 510(k) Class II Hologic, Inc.
Omni Hysteroscope, Omni Lok cervical seal

FDA 510(k) Class II Hologic, Inc.
Aptima® Chlamydia trachomatis Assay

FDA 510(k) Class I Hologic, Inc.
INVADER MTHFR 677

FDA 510(k) Class II Hologic, Inc.
INVADER FACTOR II

FDA 510(k) Class II Hologic, Inc.
Affirm Lateral Arm Upright Biopsy Accessory

FDA 510(k) Class II Hologic, Inc.
Unifi Workspace v1.0.0

FDA 510(k) Class II Hologic, Inc.

Devices 1-50 of 120

Registered as an authorised representative under EU Regulation 2017/745 (MDR) or 2017/746 (IVDR). Last verified via EUDAMED integration.