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PiCSO Impulse Cart

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Miracor Medical SA
Manufacturer SRN: BE-MF-000001089
UDI-DI: 05430002982090
Basic UDI-DI: 054300029821030021MB
Reference: 1.03.0021
EMDN: Z12059099
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 18:49

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PiCSO Impulse Power Cord, EU

PiCSO Impulse Power Cord

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Miracor Medical SA
Manufacturer SRN: BE-MF-000001089
UDI-DI: 05430002982045
Basic UDI-DI: 05430002982103000XPH
Reference: 1.03.0001
EMDN: Z12059099
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 18:49

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SCHILLER 2157-055

SKYMED

Class IMDR 2017/745Not intended for EU marketDirect markingMeasuring functionSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019818496
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-S114150-60RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

Current™

PFA Generator Accessories

Class IMDR 2017/745On the market

Manufacturer: Abbott Medical
Manufacturer SRN: US-MF-000033655
UDI-DI: 05415067051554
Basic UDI-DI: 5414734ABC00466R
Reference: PFA-ECG-CBL
EMDN: Z12059011
EMDN description: CARDIAC ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Abbott Medical
Last updated: 16.07.2026 09:58

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Fem.pop-Set

66812137-15

Class IIaMDR 2017/745On the marketSterile

Manufacturer: Sengewald Klinikprodukte GmbH
Manufacturer SRN: DE-PR-000020748
UDI-DI: 04034393797977
Basic UDI-DI: 4034393CPTCAR2AUT
Reference: 66812417-16
EMDN: Z12059099
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 08:11

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Xper Information Management System

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838100084
Basic UDI-DI: 0884838BM555TC
Reference: 830230
EMDN: Z12059092
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:21

Manufacturer products View details

IntelliSpace ECG Management System

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838118898
Basic UDI-DI: 0884838BM1901MQ
Reference: 860426
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:12

Manufacturer products 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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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