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<eudamedExport entity="devices">
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    <udiDi>08905080000822</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0180220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905080000839</udiDi>
    <basicUdiDi>8905080BPDGH</basicUdiDi>
    <tradeName>Fascial Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0200220S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:30:29.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>05701780982238</udiDi>
    <basicUdiDi>57089322978179D</basicUdiDi>
    <tradeName>EasiCath Dilatation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28318</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-28T07:50:50.119Z</lastUpdated>
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  <row>
    <udiDi>05701780982245</udiDi>
    <basicUdiDi>57089322978179D</basicUdiDi>
    <tradeName>EasiCath Dilatation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28316</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-28T07:50:50.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382609737</udiDi>
    <basicUdiDi>697209192UHD39L6</basicUdiDi>
    <tradeName>BM Urethral Dilators</tradeName>
    <deviceName>Urethral Dilators</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404 24 12 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:11:18.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382609720</udiDi>
    <basicUdiDi>697209192UHD39L6</basicUdiDi>
    <tradeName>BM Urethral Dilators</tradeName>
    <deviceName>Urethral Dilators</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404 26 22 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:11:12.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382609713</udiDi>
    <basicUdiDi>697209192UHD39L6</basicUdiDi>
    <tradeName>BM Urethral Dilators</tradeName>
    <deviceName>Urethral Dilators</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404 24 22 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:11:11.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382609706</udiDi>
    <basicUdiDi>697209192UHD39L6</basicUdiDi>
    <tradeName>BM Urethral Dilators</tradeName>
    <deviceName>Urethral Dilators</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404 22 22 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:11:10.137Z</lastUpdated>
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  <row>
    <udiDi>06942382609690</udiDi>
    <basicUdiDi>697209192UHD39L6</basicUdiDi>
    <tradeName>BM Urethral Dilators</tradeName>
    <deviceName>Urethral Dilators</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404 20 22 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:11:08.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107714</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-9.520</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107721</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-9.528</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107738</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-9.535</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107745</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-9.545</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107752</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-9.555</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107769</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-1013</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107776</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-1020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107783</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-1028</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107790</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-1035</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107806</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-1045</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214107813</udiDi>
    <basicUdiDi>697197678DXACE0301VN</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04-1055</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T15:55:48.804Z</lastUpdated>
  </row>
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