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Advantage-MR™ EP Recorder/Stimulator

Advantage-MR™ EP Recorder/Stimulator System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Imricor Medical Systems, Inc.
Manufacturer SRN: US-MF-000017310
UDI-DI: 00854277008203
Basic UDI-DI: 0854277008ADXXX42
Reference: AD900
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

NorthStar Mapping System

Class IIaMDR 2017/745On the market

Manufacturer: Imricor Medical Systems, Inc.
Manufacturer SRN: US-MF-000017310
UDI-DI: 00854277008197
Basic UDI-DI: 0854277008MAPXX69
Reference: MAP01
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 16.07.2026 06:40

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Vision-MR® Ablation Cable Set 2.0

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Imricor Medical Systems, Inc.
Manufacturer SRN: US-MF-000017310
UDI-DI: 00854277008142
Basic UDI-DI: 0854277008CABMR1XXMZ
Reference: CABA102
EMDN: C0280
EMDN description: ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 16.07.2026 06:40

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NIKOTABS

0515

Class IMDR 2017/745On the marketSingle use

Manufacturer: NIKOMED USA INC
Manufacturer SRN: US-MF-000026969
UDI-DI: 00853512006530
Basic UDI-DI: 0853512006ECGELECTRODESAJ
Reference: 0815
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:39

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Foam Pressure Applicator Handle

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007195
Basic UDI-DI: 0850298007199L
Reference: EHAN-S
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

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Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007089
Basic UDI-DI: 0850298007089F
Reference: ELDSC-5
EMDN: C020301
EMDN description: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

00850298007096

Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007096
Basic UDI-DI: 0850298007099H
Reference: ELDS-BR
EMDN: C02010401
EMDN description: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

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Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 9

Monitoring Lead Wires for Thymatron System IV 24" Set of 9

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007072
Basic UDI-DI: 0850298007079D
Reference: ELDSC-9
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

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Stick on Snap On Disposable Recording Electrodes

EEDS

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007027
Basic UDI-DI: 08502980070293
Reference: EEDS
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

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ECG Trunk Cable

GTI-00045

Class IMDR 2017/745No longer on the marketDirect marking

Manufacturer: Galvanize Therapeutics, Inc.
Manufacturer SRN: US-MF-000012701
UDI-DI: 00850033727050
Basic UDI-DI: 0850033727GTI-00045B9
Reference: GTI-00045
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Croatia
Authorised representative: Galvanize Therapeutics Germany GmbH
Last updated: 16.07.2026 06:22

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Compatibility Cable, BW ThermoCool ST

GTI-00038

Class IMDR 2017/745No longer on the marketDirect marking

Manufacturer: Galvanize Therapeutics, Inc.
Manufacturer SRN: US-MF-000012701
UDI-DI: 00850033727043
Basic UDI-DI: 0850033727GTI-00038BC
Reference: GTI-00038
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Croatia
Authorised representative: Galvanize Therapeutics Germany GmbH
Last updated: 16.07.2026 06:22

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CENTAURI Connect

GTI-00022-03

Class IMDR 2017/745No longer on the marketDirect marking

Manufacturer: Galvanize Therapeutics, Inc.
Manufacturer SRN: US-MF-000012701
UDI-DI: 00850033727029
Basic UDI-DI: 0850033727GTI-00022-03J9
Reference: GTI-00022-03
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Croatia
Authorised representative: Galvanize Therapeutics Germany GmbH
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

CENTAURI Generator

GTI-00021-01

Class IIbMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: Galvanize Therapeutics, Inc.
Manufacturer SRN: US-MF-000012701
UDI-DI: 00850033727012
Basic UDI-DI: 0850033727GTI-00021-01HW
Reference: GTI-00021-01
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Croatia
Authorised representative: Galvanize Therapeutics Germany GmbH
Last updated: 16.07.2026 06:22

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WAVE 1 Activation Materials

GTI-00036

Class IIbMDR 2017/745On the marketNo EU rep

Manufacturer: Galvanize Therapeutics, Inc.
Manufacturer SRN: US-PR-000036570
UDI-DI: 00850033727005
Basic UDI-DI: 0850033727GTI-00036B8
Reference: GTI-00036
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 06:22

Manufacturer products View details

10847946021167

ONESTEP CPR ADULT ELECTRODES

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: ZOLL Medical Corporation
Manufacturer SRN: US-MF-000021386
UDI-DI: 10847946021167
Basic UDI-DI: 08479460HST
Reference: 8900-000406-01
EMDN: C020401
EMDN description: EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
First on market country: Netherlands
Authorised representative: ZOLL International Holding B.V.
Last updated: 16.07.2026 06:06

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

PadPro

Non-orthopedic, Non-active, Monitoring Electrode, Sterile

Class IMDR 2017/745On the marketAnnex XVI applicableSingle useSterile

Manufacturer: Conmed Corporation
Manufacturer SRN: US-MF-000012663
UDI-DI: 10653405040057
Basic UDI-DI: 084585464928FD
Reference: 2502
EMDN: C020401
EMDN description: EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

CONMED

Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile

Class IMDR 2017/745On the marketSingle use

Manufacturer: Conmed Corporation
Manufacturer SRN: US-MF-000012663
UDI-DI: 10653405000891
Basic UDI-DI: 084585408541DB
Reference: 01-3130
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

00847946033965

Zenix ECG Accessories

Class IMDR 2017/745On the market

Manufacturer: ZOLL Medical Corporation
Manufacturer SRN: US-MF-000021386
UDI-DI: 00847946033965
Basic UDI-DI: 08479460BABE
Reference: 8016-000628-12
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Netherlands
Authorised representative: ZOLL International Holding B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

10840143910418

CSK-2060

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: AtriCure, Inc.
Manufacturer SRN: US-MF-000002974
UDI-DI: 10840143910418
Basic UDI-DI: 08401439000000000000011ZE
Reference: A001370-1
EMDN: C020301
EMDN description: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: AtriCure Europe B.V.
Last updated: 16.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details