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Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002305076
Basic UDI-DI: B-00827002305076
Reference: HPWAS-35-320
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002305069
Basic UDI-DI: B-00827002305069
Reference: HPWAS-35-260
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002561779
Basic UDI-DI: B-00827002561779
Reference: HPWAS-35-180
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002561755
Basic UDI-DI: B-00827002561755
Reference: HPWAS-35-80
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002561533
Basic UDI-DI: B-00827002561533
Reference: HPWS-35-180
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002561526
Basic UDI-DI: B-00827002561526
Reference: HPWS-35-150
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002561519
Basic UDI-DI: B-00827002561519
Reference: HPWS-35-80
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002304970
Basic UDI-DI: B-00827002304970
Reference: HPWS-35-320
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002304963
Basic UDI-DI: B-00827002304963
Reference: HPWS-35-260
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Roadrunner® UniGlide®

Roadrunner® UniGlide® Hydrophilic Wire Guide

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002561403
Basic UDI-DI: B-00827002561403
Reference: HPW-18-150
EMDN: C04020202
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 20.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

04255605608205

Guidewires for Central Circulatory Application

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

Manufacturer: EPflex Feinwerktechnik GmbH
Manufacturer SRN: DE-MF-000005425
UDI-DI: 04255605608205
Basic UDI-DI: 42556056gwcIIIEH
Reference: 44013524
EMDN: C0499
EMDN description: CARDIOVASCULAR GUIDEWIRES - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SSCP_gwlll · Rev. 02
Authorised representative: -
Last updated: 17.07.2026 22:44

Manufacturer products Open in EUDAMED View details

04255605608229

Class IIINot specifiedOn the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: EPflex Feinwerktechnik GmbH
Manufacturer SRN: DE-MF-000005425
UDI-DI: 04255605608229
Basic UDI-DI: 42556056gwcIIIEH
Reference: 49012949
EMDN: C0499
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): SSCP_gwlll · Rev. 02
Authorised representative: -
Last updated: 17.07.2026 22:38

Manufacturer products Open in EUDAMED View details

ARES

ARES - GW2107 - Guide Wire

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Ares Medikal Sanayi Ticaret Ltd. Şti.
Manufacturer SRN: TR-MF-000029015
UDI-DI: 86989077428446
Basic UDI-DI: B-86989077428446
Reference: ARES - GW2107 - Guide Wire
EMDN: C04020102
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Türkiye
Authorised representative: -
Last updated: 17.07.2026 04:35

Manufacturer products View details

ARES

ARES - GW2205 - Guide Wire

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Ares Medikal Sanayi Ticaret Ltd. Şti.
Manufacturer SRN: TR-MF-000029015
UDI-DI: 86989077411448
Basic UDI-DI: B-86989077411448
Reference: ARES - GW2205 - Guide Wire
EMDN: C04020102
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Türkiye
Authorised representative: -
Last updated: 17.07.2026 04:34

Manufacturer products View details

Heety

QB060700A

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Zhejiang Barty Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000007977
UDI-DI: D-69277410F8
Basic UDI-DI: B-69277410F8
Reference: QB060700A
EMDN: C04020102
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Guide Wire

OM-GW-P28260J

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Ortus Medi-Tech Co.,Ltd
Manufacturer SRN: CN-MF-000031033
UDI-DI: 06972985352181
Basic UDI-DI: B-06972985352181
Reference: OM-GW-P28260J
EMDN: C04030102
EMDN description: DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

pORTAL Steerable Hydrophilic Guidewire

Class IIIMDDOn the marketWell-established tech (possible)Single useSterile

Manufacturer: phenox GmbH
Manufacturer SRN: DE-MF-000006524
UDI-DI: 04260123781668
Basic UDI-DI: B-04260123781668
Reference: PORT-14-200-1
EMDN: C04020201
EMDN description: PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 17:12

Manufacturer products View details

06971162812562

Straight tip, J tip, Angle tip

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Tianck Medical Co., Ltd.
Manufacturer SRN: CN-MF-000007451
UDI-DI: 06971162812562
Basic UDI-DI: 697116281GW15GY
Reference: 153009
EMDN: C04020102
EMDN description: PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

ASAHI Conquest Pro

ASAHI Conquest Pro PCI Guide Wire, Confianza Pro PCI Guide Wire, ASAHI Conquest Pro 12 PCI Guide Wire, Confianza Pro 12 PCI Guide Wire

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

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327149617
Basic UDI-DI: 4547327BGW008NK
Reference: AGH143190
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C1811 · Rev. 1.01
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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

Fielder XT-A

PCI Guide Wire Fielder XT-A, PCI Guide Wire Fielder XT-R

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

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327144797
Basic UDI-DI: 4547327AGW017N7
Reference: APW14R009P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C2711 · Rev. 1
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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