<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941513204230</udiDi>
    <basicUdiDi>697005757101HB</basicUdiDi>
    <tradeName>Non-vascular Guidewires</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Vedkang Medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008462</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDK-UGW-80-150-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-25T08:55:45.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729516392</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:46.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752677</udiDi>
    <basicUdiDi>01915060000000000000613N7</basicUdiDi>
    <tradeName>Amplatz Super Stiff™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066401050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752684</udiDi>
    <basicUdiDi>01915060000000000000613N7</basicUdiDi>
    <tradeName>Amplatz Super Stiff™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066401060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752691</udiDi>
    <basicUdiDi>01915060000000000000613N7</basicUdiDi>
    <tradeName>Amplatz Super Stiff™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066401070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752707</udiDi>
    <basicUdiDi>01915060000000000000613N7</basicUdiDi>
    <tradeName>Amplatz Super Stiff™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066401080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752714</udiDi>
    <basicUdiDi>01915060000000000000613N7</basicUdiDi>
    <tradeName>Amplatz Super Stiff™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066401090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752745</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752752</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752769</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752776</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752783</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752790</udiDi>
    <basicUdiDi>01915060000000000000539NL</basicUdiDi>
    <tradeName>Zebra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0066701150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:29.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105732</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire（Zebra）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06936345105732</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:24.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105725</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire（Zebra）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06936345105725</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:23.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105701</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire（Zebra）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06936345105701</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:22.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105695</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire（Zebra）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06936345105695</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:20.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105671</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire（Zebra）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06936345105671</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:19.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105664</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire（Zebra）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06936345105664</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:18.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936345105640</udiDi>
    <basicUdiDi>69363451ZSRGWZ005CU</basicUdiDi>
    <tradeName>Guide Wire （Loach)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan ZSR Biomedical Technology Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000016828</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Guide Wire（Zebra）</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:19:17.269Z</lastUpdated>
  </row>
</eudamedExport>