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83 device results listed.

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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: 10846835035650
Basic UDI-DI: 08468350a0037FC
Reference: D141705
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: 13.10.2026 11:06

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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: 05.10.2026 22:50

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nGEN

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

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835033175
Basic UDI-DI: 08468350a0007F3
Reference: D138405
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: 05.08.2026 06:48

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NUVISION NAV Ultrasound Catheter

NUVISION

Class IIIMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835026559
Basic UDI-DI: 08468350a0047FF
Reference: FG12081
EMDN: C0104010102
EMDN description: CARDIAC AND INTRACORONARY ULTRASOUND CATHETERS
First on market country: Belgium
Safety summary (SSCP/SSP): 1159-SSCP-NUVISION · Rev. C
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 17.07.2026 05:20

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NUVISION Ultrasound Catheter

Class IIIMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835026566
Basic UDI-DI: 08468350a0047FF
Reference: FG12080
EMDN: C0104010102
EMDN description: CARDIAC AND INTRACORONARY ULTRASOUND CATHETERS
First on market country: -
Safety summary (SSCP/SSP): 1159-SSCP-NUVISION · Rev. C
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 06:37

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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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REFSTAR with QWIKPATCH External Reference Patch

CARTO 3 System External Reference Patches REFSTAR with QWIKPATCH REFSTAR PLUS with QWIKPATCH

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835000665
Basic UDI-DI: 08468350a0001EP
Reference: 34N01M
EMDN: C020105
EMDN description: NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS
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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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

Manufacturer products Authorised representative products Authorised representative actors View details

nGEN Pump

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: 10846835017458
Basic UDI-DI: 08453840a0014CW
Reference: D139701
EMDN: Z12030301
EMDN description: INFUSION PUMPS
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 16.07.2026 05:54

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MYOSTAR INJECTION CATHETER

121120S

Class IIIMDDNo longer on the marketAdministering medicineSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: D-USMF000014219000043QN
Basic UDI-DI: B-USMF000014219000043QN
Reference: 121120S
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 15.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

MYOSTAR INJECTION CATHETER

121119S

Class IIIMDDNo longer on the marketAdministering medicineSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: D-USMF000014219000042QL
Basic UDI-DI: B-USMF000014219000042QL
Reference: 121119S
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 15.07.2026 11:38

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THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER

D131801

Class IIIMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: D-USMF000014219000041QJ
Basic UDI-DI: B-USMF000014219000041QJ
Reference: D131801
EMDN: C020301
EMDN description: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 15.07.2026 11:38

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THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER

BNI35DJH

Class IIIMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: D-USMF000014219000040QG
Basic UDI-DI: B-USMF000014219000040QG
Reference: BNI35DJH
EMDN: C020301
EMDN description: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 15.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER

BNI35BBH

Class IIIMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: D-USMF000014219000039QX
Basic UDI-DI: B-USMF000014219000039QX
Reference: BNI35BBH
EMDN: C020301
EMDN description: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 15.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER

BNI35DDH

Class IIIMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: Biosense Webster, Inc
Manufacturer SRN: US-MF-000014219
UDI-DI: D-USMF000014219000038QV
Basic UDI-DI: B-USMF000014219000038QV
Reference: BNI35DDH
EMDN: C020301
EMDN description: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS
First on market country: -
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 15.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details