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220 device results listed.

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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

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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

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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

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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

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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: 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

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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

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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

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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

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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

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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

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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

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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

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Panther Fusion AdV/hMPV/RV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509290
Basic UDI-DI: 54200455DIAGPFAdVhMPVRVZ2
Reference: PRD-04330
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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Aptima Mycoplasma genitalium Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509146
Basic UDI-DI: 54200455DIAGAPTMGENY9
Reference: PRD-03374
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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Aptima Transfer Solution

Reagents and Fluids

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045508606
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: 303658
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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Panther Fusion Flu A/B/RSV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509283
Basic UDI-DI: 54200455DIAGPFFLUABRSVWG
Reference: PRD-04328
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

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Panther Fusion Internal Control-S

Panther Fusion Internal Control Reagents

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509221
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-04332
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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NovaSure Impedance Controlled Endometrial Ablation System Advanced Disposable Device

NovaSure Impedance Controlled Endometrial Ablation System

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045508224
Basic UDI-DI: 54200455GSSNOVASURENSE6
Reference: NS2013
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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NovaSure Impedance Controlled Endometrial Ablation System RF Controller Model 10

NovaSure Impedance Controlled Endometrial Ablation System

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045508187
Basic UDI-DI: 54200455GSSNOVASURERFCSJ
Reference: RFC2010
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details