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217 device results listed.

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ATEC Canister

ATEC and Eviva Breast Biopsy and Excision System

Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045503182
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: ATEC Canister
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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Aptima Specimen Transfer Kit

Collection, Transport and Lysis Kits

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500297
Basic UDI-DI: 54200455DIAGCOLLECTVT
Reference: 301154C
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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Aptima Auto Detect Kit

Reagents and Fluids

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500273
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: 303013
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: 02.07.2026 04:05

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Aptima HPV 16 18/45 Genotype Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500112
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303236
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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ATEC TriMark Titanium Biopsy Site Marker

TriMark Biopsy Site Markers

Class IIaMDR 2017/745On the marketImplantable

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503277
Basic UDI-DI: 54200455TRIMARKBSH5X
Reference: TRIMARK TD 1309
EMDN: -
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:04

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ATEC Breast Biopsy and Excision System Introducer Localization System

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

Class IIaMDR 2017/745On the market

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503192
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: ILS 0914-12
EMDN: -
EMDN description: NEEDLE INTRODUCERS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:04

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ATEC Breast Biopsy and Excision System Needle Guide

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

Class IMDR 2017/745On the market

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503109
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: ATEC NG09-LORAD
EMDN: -
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:04

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Panther Fusion Internal Control-X

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510470
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-04476
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Panther Fusion Internal Control-B

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512924
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-06234
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Aptima Specimen Diluent

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509177
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-03003
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Aptima DBS Extraction Buffer

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045511811
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04772
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Urine Transport Medium

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510937
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04943
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Blood Transport Medium

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510944
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04944
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Specimen Transport Medium

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510920
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04423
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Aptima Whole Blood Diluent

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514591
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-06783
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

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Panther Fusion GBS Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510906
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04485
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

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Aptima Chlamydia trachomatis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505414
Basic UDI-DI: 54200455DIAGAPTCTRA
Reference: 302925
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

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Aptima Combo 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512900
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05576
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Combo 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512849
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05571
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Combo 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512894
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05576
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details