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<eudamedExport entity="devices">
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    <basicUdiDi>B-00827002304895</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>HPWA-18-260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:18:05.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002305076</udiDi>
    <basicUdiDi>B-00827002305076</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-35-320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:04:12.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002305069</udiDi>
    <basicUdiDi>B-00827002305069</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-35-260</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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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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  <row>
    <udiDi>D-48012545AA</udiDi>
    <basicUdiDi>B-48012545AA</basicUdiDi>
    <tradeName>D-48012545AA</tradeName>
    <deviceName>Marsman Speedwire</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012545</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:28.701Z</lastUpdated>
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  <row>
    <udiDi>D-4101324469</udiDi>
    <basicUdiDi>B-4101324469</basicUdiDi>
    <tradeName>D-4101324469</tradeName>
    <deviceName>Marsman TeslaWire</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41013244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:16.073Z</lastUpdated>
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  <row>
    <udiDi>10845225002760</udiDi>
    <basicUdiDi>B-10845225002760</basicUdiDi>
    <tradeName>Phoenix Floppy Tip, Light Support Guidewire</tradeName>
    <deviceName>Phoenix Guidewire</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG14300LF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:36:02.694Z</lastUpdated>
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    <udiDi>06973245041968</udiDi>
    <basicUdiDi>697324504GW0010AK</basicUdiDi>
    <tradeName>06973245041968</tradeName>
    <deviceName>Guide Wires</deviceName>
    <manufacturerName>Brun Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009738</manufacturerSrn>
    <authorisedRepresentativeName>Cnovate Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000039205</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>BR-GW018-260S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:26:50.747Z</lastUpdated>
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    <udiDi>06938370135074</udiDi>
    <basicUdiDi>B-06938370135074</basicUdiDi>
    <tradeName>Surpass</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSGW-35-260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:29.650Z</lastUpdated>
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  <row>
    <udiDi>00827002075849</udiDi>
    <basicUdiDi>0827002CINC011-010_A2UV</basicUdiDi>
    <tradeName>Roadrunner®</tradeName>
    <deviceName></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-18-270</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:51.833Z</lastUpdated>
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</eudamedExport>