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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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SMARTFREEZE™

SMARTFREEZE CRYO Console Accessories

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506007522
Basic UDI-DI: 01915060000000000000212MH
Reference: M004CRBS6320
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:54

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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: 15.07.2026 22:54

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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: 15.07.2026 22:39

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Little PALS

Sensing Electrodes

Class IMDR 2017/745On the market

Manufacturer: Axelgaard Manufacturing Co., Ltd.
Manufacturer SRN: US-MF-000009382
UDI-DI: 00851913006098
Basic UDI-DI: 00856817005Sens3D
Reference: SEN 3001
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Denmark
Authorised representative: Axelgaard Manufacturing Co., Ltd.
Last updated: 15.07.2026 22:36

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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

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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

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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

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NEMEL002

NEMEL electrode patch used with the DR400

Class IMDR 2017/745On the market

Manufacturer: NorthEast Monitoring, Inc.
Manufacturer SRN: US-MF-000019819
UDI-DI: +M582NEMEL0020
Basic UDI-DI: ++M582NEMELCD
Reference: NEMEL002
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 15.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

+G177ECGMED1

SGFO3742

Class IMDR 2017/745On the marketSingle use

Manufacturer: ABINTRAX S.r.l.
Manufacturer SRN: IT-MF-000019536
UDI-DI: +G177ECGMED1
Basic UDI-DI: ++G177ECGPADWW
Reference: SGFO3742M
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 20:04

Manufacturer products View details

B938AFR000130

AFR-00013

Class IMDR 2017/745On the market

Manufacturer: Affera, Inc.
Manufacturer SRN: US-MF-000018093
UDI-DI: B938AFR000130
Basic UDI-DI: ++B938SYSCARTG9
Reference: AFR-00013
EMDN: C020180
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 15.07.2026 15:02

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B938AFR000070

AFR-00007

Class IMDR 2017/745On the marketSingle use

Manufacturer: Affera, Inc.
Manufacturer SRN: US-MF-000018093
UDI-DI: B938AFR000070
Basic UDI-DI: ++B938HEXALOCREF01AR
Reference: AFR-00007
EMDN: C020180
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 15.07.2026 15:02

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B938AFR000060

AFR-00006

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Affera, Inc.
Manufacturer SRN: US-MF-000018093
UDI-DI: B938AFR000060
Basic UDI-DI: ++B938SPH9EXTCABLEK7
Reference: AFR-00006
EMDN: C020180
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 15.07.2026 15:02

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Prism-1 Mapping System

AFR-00003

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Affera, Inc.
Manufacturer SRN: US-MF-000018093
UDI-DI: B938AFR000030
Basic UDI-DI: ++B938PRISM1HEXAMAPSYSHB
Reference: AFR-00003
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 15.07.2026 15:02

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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