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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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203 device results listed.

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

MyoSure MANUAL Tissue Removal Device

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045507937
Basic UDI-DI: 54200455GSSMANUALTRDT8
Reference: 20-401ML
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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Brevera Breast Biopsy System with CorLumina Imaging Technology

Brevera Breast Biopsy System

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045507517
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREV100
EMDN: A01020199
EMDN description: NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER
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

Aptima Herpes Simplex Viruses 1 & 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045507210
Basic UDI-DI: 54200455DIAGAPTHSV12S7
Reference: PRD-03568
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
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

Aptima Controls Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045506237
Basic UDI-DI: 54200455DIAGAPTCTGCCTRL4X
Reference: 301110
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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

Aptima Trichomonas vaginalis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505483
Basic UDI-DI: 54200455DIAGAPTTRICHWY
Reference: 303163
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
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

Aptima Neisseria gonorrhoeae

Aptima Neisseria gonorrhoeae Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505421
Basic UDI-DI: 54200455DIAGAPTGCQL
Reference: 302927
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
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

Aptima Chlamydia trachomatis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505407
Basic UDI-DI: 54200455DIAGAPTCTRA
Reference: 302925
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
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

MyoSure Control Unit

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045505124
Basic UDI-DI: 54200455GSSMYOSURECTRL5B
Reference: 10-550
EMDN: Z12080204
EMDN description: MORCELLATORS
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