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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

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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

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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

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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

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08056732652927

ECGWebApp Holter

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CARDIOLINE SpA
Manufacturer SRN: IT-MF-000029682
UDI-DI: 08056732652927
Basic UDI-DI: 0805673265012000015A
Reference: 81019595
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:32

Manufacturer products View details

DiamondTemp™

DiamondTemp Generator

Class IIbMDR 2017/745On the marketMeasuring function

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000540623
Basic UDI-DI: 0763000B000085187
Reference: CEDTG200
EMDN: Z12059011
EMDN description: CARDIAC ABLATION EQUIPMENT
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:06

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CardioInsight™

CardioInsight Mapping Vest

Class IMDR 2017/745On the marketSingle use

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000519605
Basic UDI-DI: 0763000B00006998R
Reference: CITVST0001S
EMDN: Z12059002
EMDN description: CARDIAC MAPPING EQUIPMENT
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-Heart

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Strena Medical Srl Società Benefit
Manufacturer SRN: IT-MF-000021080
UDI-DI: +G243ECG000DHR200
Basic UDI-DI: ++G243DHEARTECG4L
Reference: ECG000-DHR20
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 20:21

Manufacturer products View details

D-RHSFJ

HRS

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Aerotel Medical Systems (1998) Ltd.
Manufacturer SRN: IL-MF-000038449
UDI-DI: D-RHSFJ
Basic UDI-DI: B-RHSFJ
Reference: -
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Poland
Authorised representative: AF Pharma Service Europe SL
Last updated: 15.07.2026 05:27

Manufacturer products Authorised representative products Authorised representative actors View details

R-One Robotic Platform

Class IIbMDDOn the marketActive device

Manufacturer: ROBOCATH S.A.S
Manufacturer SRN: FR-MF-000003651
UDI-DI: D-RBH01P0000RK
Basic UDI-DI: B-RBH01P0000RK
Reference: RBH01P0000
EMDN: Z12059099
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 05:26

Manufacturer products View details

Kit Consommable R-One

R-One consumable kit

Class IMDDNo longer on the marketSingle useSterile

Manufacturer: ROBOCATH S.A.S
Manufacturer SRN: FR-MF-000003651
UDI-DI: D-RBH01C0000M4
Basic UDI-DI: B-RBH01C0000M4
Reference: RBH01C0000
EMDN: Z12059085
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 05:26

Manufacturer products View details

CorEx

2.4.1

Class IMDDOn the marketActive device

Manufacturer: Spimed-AI
Manufacturer SRN: FR-MF-000036589
UDI-DI: G532CMD0E
Basic UDI-DI: B-G532CMD0E
Reference: N/A
EMDN: Z12059082
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 00:06

Manufacturer products View details

D-Beat2PhoneEcgService6X

Beat2Phone ECG Service

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: VitalSignum Oy
Manufacturer SRN: FI-MF-000010423
UDI-DI: D-Beat2PhoneEcgService6X
Basic UDI-DI: B-Beat2PhoneEcgService6X
Reference: Beat2Phone ECG Service
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:30

Manufacturer products View details

Lithonic

Class INot specifiedOn the market

Manufacturer: Biosensors Interventional Technologies Pte Ltd
Manufacturer SRN: SG-MF-000015765
UDI-DI: 08885021690209
Basic UDI-DI: 888502169CILAMC
Reference: CILA-0004
EMDN: Z12059080
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: NVT GmbH
Last updated: 12.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details