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

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140 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

SMARTFREEZE™

Smartfreeze Cryo-Console

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729992691
Basic UDI-DI: 01915060000000000000297NK
Reference: M004CRBS4000
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

IntellaTip MiFi™

IntellaTip MiFi Filter Module

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729854388
Basic UDI-DI: 01915060000000000000207MQ
Reference: M0041212D0
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

IntellaNav™

IntellaNav Cable

Class IMDR 2017/745On the marketSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729848783
Basic UDI-DI: 01915060000000000000353N4
Reference: M004RARC010
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

IntellaTip MiFi™

IntellaTip MiFi OI CABLE

Class IMDR 2017/745On the marketSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729848745
Basic UDI-DI: 01915060000000000000352N2
Reference: M0046210
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

IntellaTip MiFi™

IntellaTip MiFi XP CABLE

Class IMDR 2017/745On the marketSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729847953
Basic UDI-DI: 01915060000000000000351MY
Reference: M0046200
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

IntellaTip MiFi™

IntellaTip MiFi Reference Cable

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729847946
Basic UDI-DI: 01915060000000000000208MS
Reference: M00436360
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

Blazer™

Blazer OI CABLE

Class IMDR 2017/745On the marketSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729792918
Basic UDI-DI: 01915060000000000000349ND
Reference: M0046910
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION 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

08714729270010

Recording System EGM Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729270010
Basic UDI-DI: 01915060000000000000209MU
Reference: M004653S0
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

08714729084570

Blazer SolidTip Ablation Catheter CABLE

Class IMDR 2017/745On the marketSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729084570
Basic UDI-DI: 01915060000000000000350MW
Reference: M0046130
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

FARASTAR™

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087181314
Basic UDI-DI: 081008718FARAGYE
Reference: M004PFCE61M400
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

FARASTAR™

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087181321
Basic UDI-DI: 081008718FARAGYE
Reference: M004PFCE61M500
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

CX-HAT 500-BSW

CX Cable

Class IMDR 2017/745On the market

Manufacturer: OSYPKA GmbH
Manufacturer SRN: DE-MF-000005610
UDI-DI: 04044508137482
Basic UDI-DI: 4044508CXCablesHX
Reference: 82013
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:09

Manufacturer products View details

PK-143-B

PK Cable

Class IMDR 2017/745On the marketSterile

Manufacturer: OSYPKA GmbH
Manufacturer SRN: DE-MF-000005610
UDI-DI: 04044508137420
Basic UDI-DI: 4044508PKCablesJR
Reference: 460041
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:09

Manufacturer products View details

TX-HAT500-SJM f

TX Cable

Class IMDR 2017/745On the marketSterile

Manufacturer: OSYPKA GmbH
Manufacturer SRN: DE-MF-000005610
UDI-DI: 04044508137208
Basic UDI-DI: 4044508TXCablesU2
Reference: 82006
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:09

Manufacturer products View details

iCONNECT - MAESTRO

iCONNECT System Cable

Class IMDR 2017/745On the market

Manufacturer: OSYPKA GmbH
Manufacturer SRN: DE-MF-000005610
UDI-DI: 04044508136980
Basic UDI-DI: 4044508iConnectSCS
Reference: 001-009077-1
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:08

Manufacturer products View details

CELSIUS - iCONNECT

iCONNECT Catheter Cable

Class IMDR 2017/745On the marketSterile

Manufacturer: OSYPKA GmbH
Manufacturer SRN: DE-MF-000005610
UDI-DI: 04044508136928
Basic UDI-DI: 4044508iConnectCBS
Reference: 001-009071-1
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:08

Manufacturer products View details