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<eudamedExport entity="devices">
  <row>
    <udiDi>06956014403303</udiDi>
    <basicUdiDi>B-06956014403303</basicUdiDi>
    <tradeName>Shun Pivot®</tradeName>
    <deviceName>Hemodialysis Catheter Kits</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610330</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:40:10.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205226</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205240</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205264</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032013</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205288</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032017</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205301</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205325</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205349</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032029</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205363</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032033</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205387</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205394</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205400</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205417</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205424</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205431</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205448</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034007</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205455</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205462</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205479</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841205486</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>Kosen</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>034011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:32.535Z</lastUpdated>
  </row>
</eudamedExport>