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<eudamedExport entity="devices">
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    <udiDi>00818075010110</udiDi>
    <basicUdiDi>B-00818075010110</basicUdiDi>
    <tradeName>Aristotle 18 Guidewire</tradeName>
    <deviceName>Aristotle 18 Guidewire</deviceName>
    <manufacturerName>Scientia Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18-200-003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:18:12.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818075010103</udiDi>
    <basicUdiDi>B-00818075010103</basicUdiDi>
    <tradeName>Aristotle 18 Guidewire</tradeName>
    <deviceName>Aristotle 18 Guidewire</deviceName>
    <manufacturerName>Scientia Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18-200-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:18:11.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818075010097</udiDi>
    <basicUdiDi>B-00818075010097</basicUdiDi>
    <tradeName>Aristotle 18 Guidewire</tradeName>
    <deviceName>Aristotle 18 Guidewire</deviceName>
    <manufacturerName>Scientia Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18-200-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:18:07.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00184360000341</udiDi>
    <basicUdiDi>B-00184360000341</basicUdiDi>
    <tradeName>ComboWire Pressure/Flow Guide Wire</tradeName>
    <deviceName>ComboWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9500</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:21.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>00184360000334</udiDi>
    <basicUdiDi>B-00184360000334</basicUdiDi>
    <tradeName>ComboWire Pressure/Flow Guide Wire</tradeName>
    <deviceName>ComboWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9515</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:19.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>00184360000150</udiDi>
    <basicUdiDi>B-00184360000150</basicUdiDi>
    <tradeName>FloWire Doppler Guide Wire</tradeName>
    <deviceName>FloWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:15.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00184360000129</udiDi>
    <basicUdiDi>B-00184360000129</basicUdiDi>
    <tradeName>FloWire Doppler Guide Wire</tradeName>
    <deviceName>FloWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1400J</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:15.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>00184360000112</udiDi>
    <basicUdiDi>B-00184360000112</basicUdiDi>
    <tradeName>FloWire Doppler Guide Wire</tradeName>
    <deviceName>FloWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:13.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464649</udiDi>
    <basicUdiDi>B-06956014464649</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626464</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:31.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464632</udiDi>
    <basicUdiDi>B-06956014464632</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626463</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:30.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464625</udiDi>
    <basicUdiDi>B-06956014464625</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626462</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:29.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464618</udiDi>
    <basicUdiDi>B-06956014464618</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626461</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:27.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464601</udiDi>
    <basicUdiDi>B-06956014464601</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guidewire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626460</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:21.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464595</udiDi>
    <basicUdiDi>B-06956014464595</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626459</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:20.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464588</udiDi>
    <basicUdiDi>B-06956014464588</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626458</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:19.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464571</udiDi>
    <basicUdiDi>B-06956014464571</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626457</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:18.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464564</udiDi>
    <basicUdiDi>B-06956014464564</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626456</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:12.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464557</udiDi>
    <basicUdiDi>B-06956014464557</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626455</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:11.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464540</udiDi>
    <basicUdiDi>B-06956014464540</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626454</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:09.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014464533</udiDi>
    <basicUdiDi>B-06956014464533</basicUdiDi>
    <tradeName>Shun Ski trails®</tradeName>
    <deviceName>Hydrophilic Coated Guide Wire</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626453</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:57:08.626Z</lastUpdated>
  </row>
</eudamedExport>