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217 device results listed.

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Aptima CMV Quant Assay Controls Kit

Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514584
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05076
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 17.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CMV Quant Assay Target Enhancer Reagent

Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514560
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05077
EMDN: W0105040299
EMDN description: CMV REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 17.07.2026 05:31

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GI Expanded Bacterial Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517509
Basic UDI-DI: 54200455DIAGPFGIEXPBACUK
Reference: PRD-07121
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GI Bacterial Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517486
Basic UDI-DI: 54200455DIAGPFGIBACUY
Reference: PRD-07113
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima SARS-CoV-2 Assay

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045516991
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07881
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514553
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05074
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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Compass Stainer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045513853
Basic UDI-DI: 54200455CYTCOMPASS2D
Reference: ASY-05576
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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ThinPrep Stain Orange G Solution

ThinPrep Staining Solutions

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045509658
Basic UDI-DI: 54200455CYTSTAIN2G
Reference: 70781-002
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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Cellient Automated Cell Block System Processor

Cellient Automated Cell Block System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045508569
Basic UDI-DI: 54200455CYTCELLIENTNX
Reference: 71959-001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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ThinPrep CytoLyt Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045508415
Basic UDI-DI: 54200455CYTCYTOLYTAY
Reference: 70953-002
EMDN: W050280
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER ACCESSORIES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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Eviva Needle Guide

ATEC and Eviva Breast Biopsy and Excision System - Needle Guides and Tissue Filter

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504608
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: EVIVA_NG09R
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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The ThinPrep Pap Test PreservCyt Solution

ThinPrep PreservCyt Solutions

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045508255
Basic UDI-DI: 54200455CYTSOLUTIONBP
Reference: 70097-003
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC Sapphire Breast Biopsy and Excision System

ATEC Sapphire Breast Biopsy and Excision System-ATEC Sapphire 200

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504110
Basic UDI-DI: 54200455ATECSapphire200KA
Reference: ATEC Sapphire 200
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC Breast Biopsy and Excision System Ultrasound Introducer

ATEC and Eviva Breast Biopsy and Excision System - Biopsy Devices and Introducers

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504561
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: AI090920
EMDN: A018003
EMDN description: NEEDLE INTRODUCERS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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Aptima Assay Fluids

Reagents and Fluids

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500280
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: 303014
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC TriMark Titanium Biopsy Site Marker

TriMark Biopsy Site Markers

Class IIaMDR 2017/745On the marketDirect markingImplantableSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503307
Basic UDI-DI: 54200455TRIMARKBSH5X
Reference: TRIMARK TD 3609
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

PreservCyt Collection Medium

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045514812
Basic UDI-DI: 54200455CYTSOLUTIONBP
Reference: PRD-07138
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

ThinPrep UroCyte PreservCyt Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045514645
Basic UDI-DI: 54200455CYTSOLUTIONBP
Reference: ASY-15510
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

ThinPrep PreservCyt Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045514782
Basic UDI-DI: 54200455CYTSOLUTIONBP
Reference: PRD-07132
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

The ThinPrep Pap Test PreservCyt Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045508286
Basic UDI-DI: 54200455CYTSOLUTIONBP
Reference: ASY-05400
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details