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<eudamedExport entity="devices">
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    <tradeName>D-4401163683</tradeName>
    <deviceName>Guidewire J20-FC-270-035/so./PTFE</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44011636</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:21.056Z</lastUpdated>
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  <row>
    <udiDi>D-440115117E</udiDi>
    <basicUdiDi>B-440115117E</basicUdiDi>
    <tradeName>D-440115117E</tradeName>
    <deviceName>Guidewire J7-FC-260/10M-035</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44011511</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:17.851Z</lastUpdated>
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    <udiDi>D-430112416P</udiDi>
    <basicUdiDi>B-430112416P</basicUdiDi>
    <tradeName>D-430112416P</tradeName>
    <deviceName>Nitinol Führungsdraht mit  J-Spitze</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43011241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:35.400Z</lastUpdated>
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    <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>D-410105015H</udiDi>
    <basicUdiDi>B-410105015H</basicUdiDi>
    <tradeName>D-410105015H</tradeName>
    <deviceName>Guidewire J3-FC-080-035</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41010501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:11.019Z</lastUpdated>
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  <row>
    <udiDi>D-410103285T</udiDi>
    <basicUdiDi>B-410103285T</basicUdiDi>
    <tradeName>D-410103285T</tradeName>
    <deviceName>Guidewire J3-FC-260-035/FS</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410102328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:07.012Z</lastUpdated>
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  <row>
    <udiDi>D-400130575P</udiDi>
    <basicUdiDi>B-400130575P</basicUdiDi>
    <tradeName>D-400130575P</tradeName>
    <deviceName>Guidewire J13-FC-270/035/PTFE</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40013057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:28.234Z</lastUpdated>
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  <row>
    <udiDi>18904314400640</udiDi>
    <basicUdiDi>B-18904314400640</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-035-STGES</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:34.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400633</udiDi>
    <basicUdiDi>B-18904314400633</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-035-AGES</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:30.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400626</udiDi>
    <basicUdiDi>B-18904314400626</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-038-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:29.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400619</udiDi>
    <basicUdiDi>B-18904314400619</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-038-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:28.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400602</udiDi>
    <basicUdiDi>B-18904314400602</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-038-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:27.642Z</lastUpdated>
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  <row>
    <udiDi>18904314400589</udiDi>
    <basicUdiDi>B-18904314400589</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-035-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:23.631Z</lastUpdated>
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  <row>
    <udiDi>18904314400596</udiDi>
    <basicUdiDi>B-18904314400596</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-038-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:22.841Z</lastUpdated>
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    <udiDi>18904314400572</udiDi>
    <basicUdiDi>B-18904314400572</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-035-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:22.031Z</lastUpdated>
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    <udiDi>18904314400565</udiDi>
    <basicUdiDi>B-18904314400565</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-035-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:21.858Z</lastUpdated>
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    <udiDi>18904314400558</udiDi>
    <basicUdiDi>B-18904314400558</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-035-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:18.556Z</lastUpdated>
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    <udiDi>18904314400541</udiDi>
    <basicUdiDi>B-18904314400541</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-032-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:18.202Z</lastUpdated>
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    <udiDi>18904314400534</udiDi>
    <basicUdiDi>B-18904314400534</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-032-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:17.855Z</lastUpdated>
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    <udiDi>18904314400527</udiDi>
    <basicUdiDi>B-18904314400527</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-032-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:17.847Z</lastUpdated>
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