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Guidewire

395536, 395200, 395513, 395451, 395770, 395206

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Argon Medical Devices, Inc.
Manufacturer SRN: US-MF-000002324
UDI-DI: 10886333210944
Basic UDI-DI: 08863332700022E
Reference: 395200
EMDN: C04020102
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type A

Zurich Medical Accessory Cable

Class IMDR 2017/745Not intended for EU market

Manufacturer: Zurich Medical
Manufacturer SRN: US-MF-000012091
UDI-DI: 00850022994012
Basic UDI-DI: 0850022994005128W
Reference: 00512-001
EMDN: C0480
EMDN description: CARDIOVASCULAR GUIDEWIRES - ACCESSORIES
First on market country: -
Authorised representative: MedR-AR Services B.V.
Last updated: 16.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

Guidewire

SGW-XXX-xx

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Galt Medical Corp.
Manufacturer SRN: US-MF-000001777
UDI-DI: 00841268100565
Basic UDI-DI: 08412681Guidewires<90cm2K
Reference: SGW-015-02
EMDN: C04020199
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES- OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Approach® Hydro ST

Approach® Hydro ST Hydrophilic Micro Wire Guide

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002529373
Basic UDI-DI: 0827002CINC011-010_A1UT
Reference: HMW-14-135-ST
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

Approach® CTO-6

Approach® Micro Wire Guide [CTO-6, CTO-12, CTO-18, CTO-25]

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002507869
Basic UDI-DI: 0827002CINC011-010_AF7
Reference: CMW-14-190-6G
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner®

Roadrunner® Extra Support Wire Guide

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002075573
Basic UDI-DI: 0827002CINC011-010_A2UV
Reference: RSTF-18-180
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

Hi-Torque Connect

1012587

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Lake Region Medical (Galway)
Manufacturer SRN: IE-MF-000035376
UDI-DI: 00816349014888
Basic UDI-DI: 081634901HTCGW82
Reference: 1012587
EMDN: C04020299
EMDN description: PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 16.07.2026 04:21

Manufacturer products View details

Victory

H74939470195120

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Lake Region Medical (Galway)
Manufacturer SRN: IE-MF-000035376
UDI-DI: 00816349012358
Basic UDI-DI: 081634901PERIPHERALGW3C
Reference: H74939472195120
EMDN: C04020299
EMDN description: PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 16.07.2026 04:21

Manufacturer products View details

Spring-Wire Guide .018" (0.46 mm) diameter x 17-3/4" (45 cm) wire / Proximal End: Solid Wire .018" diameter / Distal End: Coil .018" diameter x 9 cm

Peripheral Vascular Spring-Wire Guide Product

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Arrow International LLC (Subsidiary of Teleflex Incorporated)
Manufacturer SRN: US-MF-000024256
UDI-DI: 10801902198188
Basic UDI-DI: 08019020000000000000234KK
Reference: PW-18045
EMDN: C04020102
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Stretch™

Stretch

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729887775
Basic UDI-DI: 01915060000000000000438ND
Reference: H7493930800
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

V-14™ Control Wire™

V-14 ControlWire Guirewire

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729799207
Basic UDI-DI: 01915060000000000000492NK
Reference: H74939216718210
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

wireClip™

wireClip Torquer

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729154785
Basic UDI-DI: 01915060000000000000476NM
Reference: H802221960030
EMDN: C0480
EMDN description: CARDIOVASCULAR GUIDEWIRES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

Platinum Plus™

Platinum PlusTM Guidewire and Platinum PlusTM Guidewire with GlidexTM Hydrophilic Coating

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729035954
Basic UDI-DI: 01915060000000000000493NM
Reference: M001466010
EMDN: C04020299
EMDN description: PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

Stingray™

Stingray Extension Wire

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729837480
Basic UDI-DI: 01915060000000000000195NA
Reference: H749M3010B0
EMDN: C04010299
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES - 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

FATHOM™

Fathom Steerable Guidewire

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729762553
Basic UDI-DI: 01915060000000000000282N6
Reference: M001509100
EMDN: C04020101
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC
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

Transend™

Neuro TRANSEND GUIDEWIRE WITH ICE HYDROPHILIC COATING

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729201878
Basic UDI-DI: 01915060000000000000281N4
Reference: M003468020
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
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

V-18™ Control Wire™

V-18™ ControlWire™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729070184
Basic UDI-DI: 01915060000000000000284NA
Reference: M001468500
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
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

+B82798264J306B180A0141

MedK Cardiovascular Guidewires

Class IIIMDR 2017/745On the marketWell-established tech (possible)Single useSterile

Manufacturer: medK GmbH
Manufacturer SRN: DE-MF-000006273
UDI-DI: +B82798264J306B180A0141
Basic UDI-DI: ++B82798264LP
Reference: 98264J306B180A014
EMDN: C04030201
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: Germany
Safety summary (SSCP/SSP): medK-GW-9826 · Rev. 00
Authorised representative: -
Last updated: 15.07.2026 15:00

Manufacturer products Open in EUDAMED View details

+B82798263J05C180A0141

MedK Cardiovascular Guidewires

Class IIIMDR 2017/745On the marketWell-established tech (possible)Single useSterile

Manufacturer: medK GmbH
Manufacturer SRN: DE-MF-000006273
UDI-DI: +B82798263J05C180A0141
Basic UDI-DI: ++B82798263LM
Reference: 98263J05C180A014
EMDN: C04030201
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: Germany
Safety summary (SSCP/SSP): medK-GW-9826 · Rev. 00
Authorised representative: -
Last updated: 15.07.2026 15:00

Manufacturer products Open in EUDAMED View details

+B82798262J06A190A0141

MedK Cardiovascular Guidewires

Class IIIMDR 2017/745On the marketWell-established tech (possible)Single useSterile

Manufacturer: medK GmbH
Manufacturer SRN: DE-MF-000006273
UDI-DI: +B82798262J06A190A0141
Basic UDI-DI: ++B82798262LK
Reference: 98262J06A190A014
EMDN: C04030201
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: Germany
Safety summary (SSCP/SSP): medK-GW-9826 · Rev. 00
Authorised representative: -
Last updated: 15.07.2026 15:00

Manufacturer products Open in EUDAMED View details