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227 device results listed.

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Panther Fusion GI Expanded Bacterial Assay Controls Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517516
Basic UDI-DI: 54200455DIAGPFGIEXPBACUK
Reference: PRD-07122
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Cellient Automated Cell Block System Filter Cassette Kit

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045513938
Basic UDI-DI: 54200455CYTCELLIENTNX
Reference: 71305-001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

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Cellient Automated Cell Block System Finishing Station

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001677
UDI-DI: 15420045508576
Basic UDI-DI: 54200455CYTCELLIENTNX
Reference: 71664-001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

MammoPad

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Hologic Inc.
Manufacturer SRN: US-MF-000003332
UDI-DI: 45420045505668
Basic UDI-DI: 54200455MAMMOPADNJ
Reference: MP101
EMDN: Z11030285
EMDN description: MAMMOGRAPHY SYSTEMS - CONSUMABLES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Fluent Fluid Management System Tissue Trap

Fluent Fluid Management System Waste Bag; Fluent Fluid Management System Tissue Trap; Fluent Pro Fluid Management System Waste Bag; Fluent Pro Fluid Management System Tissue Trap

Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 25420045505275
Basic UDI-DI: 54200455GSSFLUENTMULTIH7
Reference: FLT-010
EMDN: A080299
EMDN description: INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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Omni Instrument Tray

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045516595
Basic UDI-DI: 54200455GSSSCOPETRAYZR
Reference: 60-903-1
EMDN: S010401
EMDN description: TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Fluent Pro Fluid Management System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045516212
Basic UDI-DI: 54200455GSSFLUENTSYSZL
Reference: FLT-200
EMDN: Z12030301
EMDN description: INFUSION PUMPS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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Fluent Pro Fluid Management System Procedure Kit

Fluent Pro Fluid Management System Disposable Procedure Kit

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045516144
Basic UDI-DI: 54200455GSSFLUENTDISPZN
Reference: FLT-212S
EMDN: A080201
EMDN description: INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CMV Quant Assay Calibrator

Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514577
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05075
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Faxitron Core Specimen Radiography System

Faxitron Radiography System

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic Inc.
Manufacturer SRN: US-MF-000003332
UDI-DI: 15420045514218
Basic UDI-DI: 54200455FAXITRONCABXRAYBU
Reference: COREVISION5X10
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

TruNode Single-Use Gamma Probe

TruNode Gamma Probe System

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045512856
Basic UDI-DI: 54200455TRUNODEBSHD6
Reference: 120-807605
EMDN: Z11029001
EMDN description: BETA/GAMMA DETECTORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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: 15420045512832
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: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trident HD Specimen Radiography System

Trident® HD Specimen Radiography System

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic Inc.
Manufacturer SRN: US-MF-000003332
UDI-DI: 15420045512214
Basic UDI-DI: 54200455TRIDENTHDDN
Reference: TRI-00002
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Omni Lok Cervical Seal

Omni Lok Cervical Seal; Omni 5Fr Seal Cap; MyoSure Single Use Seal

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045512191
Basic UDI-DI: 54200455GSSSCOPESEALWP
Reference: OLK-100
EMDN: Z12020785
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CV/TV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512061
Basic UDI-DI: 54200455DIAGAPTCVTV2E
Reference: PRD-05189
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima BV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512023
Basic UDI-DI: 54200455DIAGAPTBVRB
Reference: PRD-05186
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GBS Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510890
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04484
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion MRSA Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510401
Basic UDI-DI: 54200455DIAGPFMRSADE
Reference: PRD-04803
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509542
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 302929
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Paraflu Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509306
Basic UDI-DI: 54200455DIAGPFPARAFLURZ
Reference: PRD-04329
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details