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

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CR™

Injection Electrode

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250012194
Basic UDI-DI: 01915060000000000000502MV
Reference: CR-6
EMDN: K02030101
EMDN description: RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:46

Manufacturer products Authorised representative products Authorised representative actors View details

electrodeCP™

Injection Electrode

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250012170
Basic UDI-DI: 01915060000000000000498NX
Reference: CP-6
EMDN: K02030101
EMDN description: RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:46

Manufacturer products Authorised representative products Authorised representative actors View details

needleCN™

Injection Electrode

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250012156
Basic UDI-DI: 01915060000000000000501MT
Reference: CN-6
EMDN: K02030101
EMDN description: RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:46

Manufacturer products Authorised representative products Authorised representative actors View details

00813250011630

RF Cable, RF Adapter Plug

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250011630
Basic UDI-DI: 01915060000000000000079N7
Reference: CB114-TC
EMDN: K020380
EMDN description: DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:46

Manufacturer products Authorised representative products Authorised representative actors View details

CSK™

Non-CNS Electrode (Re-usable)

Class IIbMDR 2017/745On the marketCMR substance

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250010091
Basic UDI-DI: 01915060000000000000199NJ
Reference: CSK-TC5
EMDN: L180601
EMDN description: OPEN ELECTROSURGERY ELECTRODES, REUSABLE
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:46

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Visual-ICE™

Visual Ice MRI Cryoablation System

Class IIbMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506036522
Basic UDI-DI: 01915060000000000000395NL
Reference: H7493961070000
EMDN: Z120102
EMDN description: CRYOSURGERY EQUIPMENT
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

Visual-ICE™

Visual-ICE

Class IIbMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506021962
Basic UDI-DI: 01915060000000000000317MY
Reference: H7493960960000
EMDN: Z120102
EMDN description: CRYOSURGERY EQUIPMENT
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

ICEfx™

ICEfx Cryoablation System

Class IIbMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506014995
Basic UDI-DI: 01915060000000000000257N7
Reference: H749396118000
EMDN: Z120102
EMDN description: CRYOSURGERY EQUIPMENT
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

SideKick™

Cannula

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00191506013097
Basic UDI-DI: 01915060000000000000203MG
Reference: RFK-C101018S-ZK2
EMDN: K02030106
EMDN description: RADIOFREQUENCY SURGERY CANNULAS, SINGLE-USE
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:42

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WATCHMAN FLX™

WATCHMAN FLX Pro

Class IIIMDR 2017/745On the marketCMR substanceImplantableSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506004644
Basic UDI-DI: 01915060000000000000569NV
Reference: M635WS60200
EMDN: P070404
EMDN description: LEFT ATRIAL APPENDAGE OCCLUDERS
First on market country: Netherlands
Safety summary (SSCP/SSP): 97172041 · Rev. C
Authorised representative: Boston Scientific Limited
Last updated: 13.10.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AutoElite

Class IIbNot specifiedOn the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506047849
Basic UDI-DI: 01915060000000000000572NJ
Reference: M001AJAEC0200
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 12.10.2026 22:44

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ROTAPRO™

Class IIbNot specifiedNot intended for EU market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729975076
Basic UDI-DI: 01915060000000000000427N8
Reference: H74939309010
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.10.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

00813250011746

Footswitch

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250011746
Basic UDI-DI: 01915060000000000000080MQ
Reference: FS-1
EMDN: K020380
EMDN description: DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 07.10.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

00813250011791

Test Plug

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250011791
Basic UDI-DI: 01915060000000000000081MS
Reference: RFG-TP
EMDN: K020380
EMDN description: DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 07.10.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

CSK™

Sterilizable Case

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250011470
Basic UDI-DI: 01915060000000000000082MU
Reference: CSK-CASE
EMDN: K020380
EMDN description: DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 07.10.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

electrodeCP™

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Neuromodulation Corporation
Manufacturer SRN: US-MF-000004703
UDI-DI: 00813250012187
Basic UDI-DI: 01915060000000000000498NX
Reference: CP-10
EMDN: K02030101
EMDN description: RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 07.10.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Transend™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729201212
Basic UDI-DI: 01915060000000000000281N4
Reference: M001468060
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 05.10.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Transend™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729326250
Basic UDI-DI: 01915060000000000000281N4
Reference: M001468070
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 05.10.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Transend™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729326267
Basic UDI-DI: 01915060000000000000281N4
Reference: M001468080
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 05.10.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Transend™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729441731
Basic UDI-DI: 01915060000000000000281N4
Reference: M003468140
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 05.10.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details