<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936881134340</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>U03B011255</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134357</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>U03B011413</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134364</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>U03B011420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134371</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>U03B011428</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134395</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>U03B011445</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134401</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</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>U03B011455</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948130</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948130</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE14F600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:52.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948123</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948123</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE14F550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:50.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948116</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948116</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE14F500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:48.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948109</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948109</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE14F460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:46.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948093</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948093</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE13F600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:42.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948079</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948079</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE13F500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:39.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948062</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948062</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE13F460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:38.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948055</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948055</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE12F600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:35.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948048</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948048</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE12F550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:30.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948031</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948031</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE12F500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:28.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948024</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948024</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE12F460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:27.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948017</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948017</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE11F600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:24.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033948000</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033948000</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE11F550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:21.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033947997</udiDi>
    <basicUdiDi>69509009CENPSQA</basicUdiDi>
    <tradeName>06942033947997</tradeName>
    <deviceName>Sterile, Single Use Ureteral Access Sheath</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPSCE11F500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:27:17.648Z</lastUpdated>
  </row>
</eudamedExport>