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83 device results listed.

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Rhythmia HDx™

Rhythmia HDx Patch Kit

Class IMDR 2017/745On the marketSingle use

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506000813
Basic UDI-DI: 01915060000000000000215MP
Reference: M004RAPATCH20
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

RHYTHMIA HDx™

Ablation Connection Box – IntellaNav StablePoint (for INTELLAGEN)

Class IMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506020798
Basic UDI-DI: 01915060000000000000452N7
Reference: M004RA63020
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Rhythmia HDx™

Ablation Connection Box (for INTELLAGEN)

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506020804
Basic UDI-DI: 01915060000000000000453N9
Reference: M004RA65010
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Rhythmia HDx™

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506034382
Basic UDI-DI: 01915060000000000000453N9
Reference: M004RA6501D0
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

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OPAL HDx™

OPAL HDx™ Mapping System Workstation PC

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506055301
Basic UDI-DI: 01915060000000000000600MW
Reference: M004OPAL40100
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

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OPAL HDx™

OPAL HDx™ Mapping System Signal Station

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506055325
Basic UDI-DI: 01915060000000000000599P6
Reference: M004OPAL10200
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

OPAL HDx™

OPAL HDx™ Mapping System

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506056476
Basic UDI-DI: 01915060000000000000598P4
Reference: M004OPALINSTLLROW0
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

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vMap

Vektor Computational ECG Mapping System (vMap)

Class IIaMDR 2017/745On the market

Manufacturer: Vektor Medical Inc.
Manufacturer SRN: US-MF-000047086
UDI-DI: 00860007954153
Basic UDI-DI: 00860007954DP-1000vMapBD
Reference: 714-00001
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Belgium
Authorised representative: Veranex Germany GmbH
Last updated: 02.08.2026 22:28

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Khelix Diagnostic Extension Cable 20pin

Khelix Diagnostic Extension Cable

Class IMDDOn the marketReusableSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000135
Basic UDI-DI: B-09351351000135
Reference: X-D20
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 01:10

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Khelix Diagnostic Extension Cable 10pin

Khelix Diagnostic Extension Cable

Class IMDDOn the marketReusableSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000128
Basic UDI-DI: B-09351351000128
Reference: X-D10
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 01:10

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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

Manufacturer products Authorised representative products Authorised representative actors View details

Affera™

Affera Integrated Mapping System

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000998288
Basic UDI-DI: 0763000B00031988K
Reference: AFR-00016
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:09

Manufacturer products Authorised representative products Authorised representative actors View details

Affera™

Affera Mapping System

Class IIaMDR 2017/745On the market

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000871932
Basic UDI-DI: 0763000B000263083
Reference: AFR-00003
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

RHYTHMIA HDx™

Foot Switch

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729948384
Basic UDI-DI: 01915060000000000000214MM
Reference: M004RH15010
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

RHYTHMIA HDx™

Rhythmia HDx Cable

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729938507
Basic UDI-DI: 01915060000000000000213MK
Reference: M004RA5010A0
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

SynX

1.2

Class IMDR 2017/745On the marketActive device

Manufacturer: Stereotaxis, Inc.
Manufacturer SRN: US-MF-000026621
UDI-DI: M58800101480010
Basic UDI-DI: ++M5880010148001EY
Reference: 001-014800-1
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Synchrony

Class IMDR 2017/745On the market

Manufacturer: Stereotaxis, Inc.
Manufacturer SRN: US-MF-000026621
UDI-DI: M58800101070010
Basic UDI-DI: ++M5880010107001DD
Reference: 001-010700-1
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Hungary
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 21:59

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Odyssey Cinema

DMS-100

Class IMDR 2017/745On the marketActive device

Manufacturer: Stereotaxis, Inc.
Manufacturer SRN: US-MF-000026621
UDI-DI: M58802000780040
Basic UDI-DI: ++M588020007800NB
Reference: 020-007800-4
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Poland
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Odyssey Vision

Quad HD

Class IMDR 2017/745On the marketActive device

Manufacturer: Stereotaxis, Inc.
Manufacturer SRN: US-MF-000026621
UDI-DI: M58800100701020
Basic UDI-DI: ++M588001007010LH
Reference: 001-007010-2
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Norway
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details