<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06959956515837</udiDi>
    <basicUdiDi>69599565PCNLP8J</basicUdiDi>
    <tradeName>PCNL package</tradeName>
    <deviceName>PCNL package</deviceName>
    <manufacturerName>Hunan Reborn Medical Science and Technology Development Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023648</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT(F8,F10,F12,F14,F16,F18),PS(F18),BNT(F14),DPN,G800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:26:44.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959956515820</udiDi>
    <basicUdiDi>69599565PCNLP8J</basicUdiDi>
    <tradeName>PCNL package</tradeName>
    <deviceName>PCNL package</deviceName>
    <manufacturerName>Hunan Reborn Medical Science and Technology Development Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023648</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT(F8,F10,F12,F14,F16,F18),PS(F18),BNT(F14),DPN,G500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:26:43.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610498</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 22 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:14:04.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610481</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 20 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:14:03.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610474</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 18 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:14:01.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610467</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 16 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:14:00.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610450</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 14 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:13:53.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610443</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 12 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:13:52.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610436</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 10 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:13:51.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382610429</udiDi>
    <basicUdiDi>697209192PNS26MT</basicUdiDi>
    <tradeName>BM Percutaneous Nephrostomy Sets</tradeName>
    <deviceName>Percutaneous Nephrostomy Sets</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>U040201</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401 08 02 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:13:50.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729298144</udiDi>
    <basicUdiDi>01915060000000000000602N2</basicUdiDi>
    <tradeName>08714729298144</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>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067001230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:48.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729826484</udiDi>
    <basicUdiDi>01915060000000000000531N4</basicUdiDi>
    <tradeName>NephroMax™</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>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062101400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:06.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729826491</udiDi>
    <basicUdiDi>01915060000000000000531N4</basicUdiDi>
    <tradeName>NephroMax™</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>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062101420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:06.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729826507</udiDi>
    <basicUdiDi>01915060000000000000531N4</basicUdiDi>
    <tradeName>NephroMax™</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>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062101440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:06.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729953364</udiDi>
    <basicUdiDi>01915060000000000000602N2</basicUdiDi>
    <tradeName>NaviGuide™</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>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067001310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:13:46.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729953371</udiDi>
    <basicUdiDi>01915060000000000000602N2</basicUdiDi>
    <tradeName>NaviGuide™</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>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067001320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:13:46.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729953388</udiDi>
    <basicUdiDi>01915060000000000000602N2</basicUdiDi>
    <tradeName>NaviGuide™</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>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067001330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:13:46.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021111</udiDi>
    <basicUdiDi>081226101DCS007LH</basicUdiDi>
    <tradeName>DRAINAGE CATHETER &amp; SETS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UBC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>14026704728463</udiDi>
    <basicUdiDi>08019020000000000000252KM</basicUdiDi>
    <tradeName>Exchange set for percutan. nephrostomy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340014-000080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T16:36:17.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>14026704728470</udiDi>
    <basicUdiDi>08019020000000000000252KM</basicUdiDi>
    <tradeName>Exchange set for percutan. nephrostomy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040299</emdnCode>
    <emdnDescription>DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340014-000100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T16:36:17.013Z</lastUpdated>
  </row>
</eudamedExport>