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EUDAMED Device Search

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

Last updated

05.07.2026 22:34

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203 device results listed.

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Aptima HPV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509573
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 303093
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509580
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 303093
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509726
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: EVIVA_ADAPTER
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

EVIVA_ADAPTER_MTEST

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509740
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: EVIVA_ADAPTER_MTEST
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

EVIVA_STYLET_BRACKET

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509757
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: EVIVA_STYLET_BRACKET
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

EVIVA_NG_HOLDER

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509764
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: EVIVA_NG_HOLDER
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509771
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: FAB-06337
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509832
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: ATEC STX-2
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

EVIVA_BUSHING_GE

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509948
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: EVIVA_BUSHING_GE
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

EVIVA_CALIBRATE_13CM

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045509962
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: EVIVA_CALIBRATE_13CM
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion MRSA Assay Controls

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510449
Basic UDI-DI: 54200455DIAGPFMRSADE
Reference: PRD-04805
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

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Aptima CV/TV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512078
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: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CV/TV Assay Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512092
Basic UDI-DI: 54200455DIAGAPTCVTV2E
Reference: PRD-05190
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 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brevera Breast Biopsy System Standard Stereotactic Biopsy Needle

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Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045512863
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREVDISP09
EMDN: A01020199
EMDN description: NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brevera Breast Biopsy System Single Chamber Tissue Filter

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Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045513761
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREVTF01
EMDN: A01020199
EMDN description: NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brevera Breast Biopsy System 12 Chamber Tissue Filter

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Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045513778
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREVTF12
EMDN: A01020199
EMDN description: NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omni 5 Fr. Seal Cap

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Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045513839
Basic UDI-DI: 54200455GSSSCOPESEALWP
Reference: 60-5FR
EMDN: Z12020785
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruNode User Feedback Unit

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Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045514638
Basic UDI-DI: 54200455TRUNODEBSHD6
Reference: 120-807611
EMDN: Z11029001
EMDN description: BETA/GAMMA DETECTORS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device

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Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045515154
Basic UDI-DI: 54200455GSSNOVASURENSE6
Reference: NSV5-001
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brevera Breast Biopsy System Driver

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Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045515161
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREVDRV
EMDN: A01020199
EMDN description: NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details