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EUDAMED Device Search

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

Last updated

31.07.2026 19:58

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161 device results listed.

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Fusion® Pre-Loaded OMNI-TOME

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002486768
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-21-480
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:59

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® OMNI-TOME® Pre-Loaded Sphincterotome

Sphincterotomes

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002558144
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-35-260
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® OMNI-TOME® Pre-Loaded Sphincterotome

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002558151
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-35-480
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® OMNI-TOME® Pre-Loaded Sphincterotome

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002561038
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-21-260
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

D.A.S.H® Pre-loaded with Acrobat® 2 Wire Guide

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002572980
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-AWG2-25-450
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

D.A.S.H® Pre-loaded with Acrobat® 2 Wire Guide

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002572997
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-AWG2-35-260
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

D.A.S.H® Pre-loaded with Acrobat® 2 Wire Guide

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002573000
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-AWG2-35-450
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® OMNI Pre-Loaded with Acrobat® 2 Wire Guide

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002573017
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-AWG2-35-205
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® OMNI Pre-Loaded with Acrobat® 2 Wire Guide

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002573024
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-AWG2-35-260
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® OMNI Pre-Loaded with Acrobat® 2 Wire Guide

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002573031
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-AWG2-35-450
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

SureTome™ SW Sphincterotome with DomeTip®

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002613515
Basic UDI-DI: 0827002WCM00000000046MY
Reference: SUR-SW-AWG2-35-260
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

SureTome™ SW Sphincterotome with DomeTip®

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002613522
Basic UDI-DI: 0827002WCM00000000046MY
Reference: SUR-SW-AWG2-35-450
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 26.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Howell D.A.S.H® Direct Access System

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002252271
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-480
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 25.07.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

D.A.S.H® DomeTip® Double Lumen Sphincterotome

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002256668
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-35-480
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 25.07.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

Howell D.A.S.H® Sphincterotome

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Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002257900
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-21-480
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 25.07.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

Fusion® Pre-Loaded OMNI-TOME

Sphincterotomes

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002319110
Basic UDI-DI: 0827002WCM00000000046MY
Reference: FS-OMNI-35
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 25.07.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

Howell D.A.S.H® Direct Access System

Howell D.A.S.H Direct Access System

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Wilson-Cook Medical, Inc.
Manufacturer SRN: US-MF-000002658
UDI-DI: 00827002252257
Basic UDI-DI: 0827002WCM00000000046MY
Reference: DASH-260
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

TRUEtome Jag Cannulating Sphincterotome

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729858621
Basic UDI-DI: 01915060000000000000575NQ
Reference: M00583080
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

TRUEtome™ Dreamwire™

TRUEtome Dreamwire Cannulating Sphincterotome

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729858720
Basic UDI-DI: 01915060000000000000577NU
Reference: M00583180
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

TRUEtome Hydra Cannulating Sphincterotome

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729858706
Basic UDI-DI: 01915060000000000000576NS
Reference: M00583160
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details