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myPatch®sl lead wire, 13"

3000sl Accessory

Class IMDR 2017/745On the market

Manufacturer: dms-service, LLC
Manufacturer SRN: US-MF-000008977
UDI-DI: 00857522005064
Basic UDI-DI: 0857522005mpE3slVB
Reference: mpLW13
EMDN: Z12050480
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: QNET B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPULSE Generator

TRUPULSE

Class IIbMDR 2017/745Not intended for EU marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster (Israel) Ltd.
Manufacturer SRN: IL-MF-000017055
UDI-DI: 10846835025705
Basic UDI-DI: 08468350a0042F5
Reference: D141701IL
EMDN: Z12059011
EMDN description: CARDIAC ABLATION EQUIPMENT
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:06

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TRUPULSE Generator

TRUPULSE

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835025231
Basic UDI-DI: 08468350a0037FC
Reference: D141701
EMDN: Z12059011
EMDN description: CARDIAC ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:06

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nGEN

nGEN Generator

Class IIbMDR 2017/745Not intended for EU marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster (Israel) Ltd.
Manufacturer SRN: IL-MF-000017055
UDI-DI: 10846835024425
Basic UDI-DI: 08468350a0033F4
Reference: D138403IL
EMDN: Z12059011
EMDN description: CARDIAC ABLATION EQUIPMENT
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:06

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TX eco Cable

Class IIbMDR 2017/745Not intended for EU marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster (Israel) Ltd.
Manufacturer SRN: IL-MF-000017055
UDI-DI: 10846835021882
Basic UDI-DI: 08468350a0036FA
Reference: D140102IL
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:06

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TX eco Cable

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835017427
Basic UDI-DI: 08468350a0025F5
Reference: D140102
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:06

Manufacturer products Authorised representative products Authorised representative actors View details

nGEN

nGEN Generator

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835016109
Basic UDI-DI: 08468350a0007F3
Reference: D138401
EMDN: Z12059011
EMDN description: CARDIAC ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:05

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CARTO 3 SYSTEM

CARTO 3 System

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835015669
Basic UDI-DI: 08468350a0024F3
Reference: FG540000U
EMDN: Z12059002
EMDN description: CARDIAC MAPPING EQUIPMENT
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:05

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SMARTABLATE Irrigation Tubing Set

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835009743
Basic UDI-DI: 08468350a0005EX
Reference: SAT001
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:05

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CARTO 3 System Interface cable

CARTO 3 System Interface Cables

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835009422
Basic UDI-DI: 08468350a0004EV
Reference: D129704
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:05

Manufacturer products Authorised representative products Authorised representative actors View details

CARTO 3 SYSTEM

CARTO 3 System

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Biosense Webster (Israel) Ltd.
Manufacturer SRN: IL-MF-000017055
UDI-DI: 10846835000870
Basic UDI-DI: 08468350a0002ER
Reference: FG540000
EMDN: Z12059002
EMDN description: CARDIAC MAPPING EQUIPMENT
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:05

Manufacturer products Authorised representative products Authorised representative actors View details

INTERFACE CABLE

SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter

Class IMDR 2017/745No longer on the marketDirect markingSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835000184
Basic UDI-DI: 08468350a0003ET
Reference: SW1170016
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:05

Manufacturer products Authorised representative products Authorised representative actors View details

NUVISION Connector Cable

NUVISION Ultrasound Connector Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 00860005688111
Basic UDI-DI: 08468350a0043F7
Reference: FG10594
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

LiDCO to Philips, Analog Cable

LiDCO Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Masimo Corporation
Manufacturer SRN: US-MF-000010641
UDI-DI: 00843997002011
Basic UDI-DI: 084399700000Z7T0C01V007LP
Reference: 5127
EMDN: Z12050702
EMDN description: POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

LiDCO to Merit Medical, BP Module Cable

LiDCO Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Masimo Corporation
Manufacturer SRN: US-MF-000010641
UDI-DI: 00843997001892
Basic UDI-DI: 084399700000Z7T0C01V006LM
Reference: 5120
EMDN: Z12050702
EMDN description: POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 05:19

Manufacturer products Authorised representative products Authorised representative actors View details

LiDCO Module

Class IIbMDR 2017/745On the marketDirect marking

Manufacturer: Masimo Corporation
Manufacturer SRN: US-MF-000010641
UDI-DI: 00843997001823
Basic UDI-DI: 084399700000Z7T4C01V000NM
Reference: 95059
EMDN: Z12050702
EMDN description: POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 05:19

Manufacturer products Authorised representative products Authorised representative actors View details

LIFECARD CF DIGITAL HOLTER MON

Lifecard

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522131097
Basic UDI-DI: 08415221ICFCLCFOEM8P
Reference: LCF
EMDN: Z12050404
EMDN description: BLOOD PRESSURE HOLTER RECORDERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse Mini

Class IMDR 2017/745On the marketActive device

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522130304
Basic UDI-DI: 08415221IEMPATCHOWNBU
Reference: 712-1053-01
EMDN: Z12050485
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

ECLIPSE PRO RECORDER,MULTILINGUAL

Eclipse Pro

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522128851
Basic UDI-DI: 08415221IIa98700OWNJ9
Reference: 98700
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

LIFESCREEN PRO ANALYSER, V1.X

Lifescreen Pro

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Spacelabs Healthcare Ltd
Manufacturer SRN: GB-MF-000001196
UDI-DI: 10841522128837
Basic UDI-DI: 08415221IIa98800OWNJN
Reference: LSPRO
EMDN: Z12050401
EMDN description: CARDIOVASCULAR HOLTER ANALYSERS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details