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EUDAMED Device Search

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

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227 device results listed.

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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: 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

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

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

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

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

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

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

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

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

Brevera Breast Biopsy System Standard Stereotactic Biopsy Needle

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045515482
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREVDISP07
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 Needle Guide

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045515499
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREV-NG07R
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 Needle Guide

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045515505
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREV-NG07L
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

Aptima CV/TV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517073
Basic UDI-DI: 54200455DIAGAPTCVTV2E
Reference: PRD-07665
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

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517080
Basic UDI-DI: 54200455DIAGAPTCVTV2E
Reference: PRD-07665
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 Tissue Filter Base

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045518384
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREVTFB
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

ATEC Breast Biopsy and Excision System Needle Guide

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503123
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: ATEC NG12-LORAD
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.06.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC Breast Biopsy and Excision System Needle Guide

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503130
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: ATEC NG12-FISCH
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.06.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC Breast Biopsy and Excision System Aurora Angled Needle Guide

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503154
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: ATEC_NG09-A2
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.06.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC Breast Biopsy and Excision System Tissue Filter

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503161
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: ATEC TF-1
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.06.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

ATEC Breast Biopsy and Excision System Remote Tissue Filter Adapter

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 05420045503178
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: ATEC RTFA
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.06.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details