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<eudamedExport entity="devices">
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    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWAS-35-260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:04:09.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002561779</udiDi>
    <basicUdiDi>B-00827002561779</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWAS-35-180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:58:00.618Z</lastUpdated>
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  <row>
    <udiDi>00827002561755</udiDi>
    <basicUdiDi>B-00827002561755</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWAS-35-80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:57:59.810Z</lastUpdated>
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  <row>
    <udiDi>00827002561533</udiDi>
    <basicUdiDi>B-00827002561533</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWS-35-180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:57:59.010Z</lastUpdated>
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  <row>
    <udiDi>00827002561526</udiDi>
    <basicUdiDi>B-00827002561526</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWS-35-150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:51:54.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002561519</udiDi>
    <basicUdiDi>B-00827002561519</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWS-35-80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:51:50.234Z</lastUpdated>
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  <row>
    <udiDi>00827002304970</udiDi>
    <basicUdiDi>B-00827002304970</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWS-35-320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:51:48.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002304963</udiDi>
    <basicUdiDi>B-00827002304963</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPWS-35-260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:51:47.825Z</lastUpdated>
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  <row>
    <udiDi>00827002561403</udiDi>
    <basicUdiDi>B-00827002561403</basicUdiDi>
    <tradeName>Roadrunner® UniGlide®</tradeName>
    <deviceName>Roadrunner® UniGlide® Hydrophilic Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPW-18-150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:37:51.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077428446</udiDi>
    <basicUdiDi>B-86989077428446</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Guide Wire</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - GW2107 - Guide Wire</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:35:14.447Z</lastUpdated>
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  <row>
    <udiDi>86989077411448</udiDi>
    <basicUdiDi>B-86989077411448</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Guide Wire</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - GW2205 - Guide Wire</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:56.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69277410F8</udiDi>
    <basicUdiDi>B-69277410F8</basicUdiDi>
    <tradeName>Heety</tradeName>
    <deviceName>Catheter Sheath Sets</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QB060700A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:21.710Z</lastUpdated>
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  <row>
    <udiDi>04260123781668</udiDi>
    <basicUdiDi>B-04260123781668</basicUdiDi>
    <tradeName>pORTAL Steerable Hydrophilic Guidewire</tradeName>
    <deviceName>pORTAL Steerable Hydrophilic Guidewire</deviceName>
    <manufacturerName>phenox GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020201</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PORT-14-200-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:12:16.106Z</lastUpdated>
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    <udiDi>06971162812562</udiDi>
    <basicUdiDi>697116281GW15GY</basicUdiDi>
    <tradeName>06971162812562</tradeName>
    <deviceName>Guidewire</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:59:09.284Z</lastUpdated>
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    <udiDi>10886333211675</udiDi>
    <basicUdiDi>08863332700102D</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>Guidewire</deviceName>
    <manufacturerName>Argon Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395539</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:33:33.260Z</lastUpdated>
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    <udiDi>10886333210944</udiDi>
    <basicUdiDi>08863332700022E</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>Guidewire</deviceName>
    <manufacturerName>Argon Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:33:26.848Z</lastUpdated>
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    <udiDi>00841268100565</udiDi>
    <basicUdiDi>08412681Guidewires&lt;90cm2K</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>Guidewires with a Maximum Length of 90cm</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020199</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGW-015-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:09:30.706Z</lastUpdated>
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    <udiDi>00827002529373</udiDi>
    <basicUdiDi>0827002CINC011-010_A1UT</basicUdiDi>
    <tradeName>Approach® Hydro ST</tradeName>
    <deviceName>Approach® Hydro ST Hydrophilic Micro Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMW-14-135-ST</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:44.229Z</lastUpdated>
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    <udiDi>00827002507869</udiDi>
    <basicUdiDi>0827002CINC011-010_AF7</basicUdiDi>
    <tradeName>Approach® CTO-6</tradeName>
    <deviceName>Approach® Micro Wire Guide [CTO-6, CTO-12, CTO-18, CTO-25]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMW-14-190-6G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:43.432Z</lastUpdated>
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    <udiDi>00827002075573</udiDi>
    <basicUdiDi>0827002CINC011-010_A2UV</basicUdiDi>
    <tradeName>Roadrunner®</tradeName>
    <deviceName>Roadrunner® Extra Support Wire Guide</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSTF-18-180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:43:59.644Z</lastUpdated>
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</eudamedExport>