<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08714729839095</udiDi>
    <basicUdiDi>01915060000000000000540N5</basicUdiDi>
    <tradeName>Navigator™</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>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062502290</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:05.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374020596</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX DUO URETERAL ACCESS SHEATH- DUAL LUMEN</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UFDL14/12-36</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374020602</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX DUO URETERAL ACCESS SHEATH- DUAL LUMEN</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UFDL14/12-46</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021609</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX URETERAL ACCESS SHEATH</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00819374021609</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482232</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482249</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1A00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482256</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1A01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482263</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1B00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482270</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1B01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482287</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1C00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482294</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1C01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482300</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1D00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972197482317</udiDi>
    <basicUdiDi>697219748UA01ND</basicUdiDi>
    <tradeName>Single-use Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Vathin Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002593</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S1D01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:23.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>60913190405536</udiDi>
    <basicUdiDi>60913190UDB-039G</basicUdiDi>
    <tradeName>Tahina 0.038" Nephrostomy Balloon Dilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENVASTE LTD</manufacturerName>
    <manufacturerSrn>MU-MF-000030801</manufacturerSrn>
    <authorisedRepresentativeName>ENVASTE LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000028866</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDB-0310120S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:51:53.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261015286</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX URETERAL ACCESS SHEATH</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:22:35.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261019741</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX URETERAL ACCESS SHEATH</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:22:34.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261019758</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-FLEX URETERAL ACCESS SHEATH</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:22:34.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374028011</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-Flex Ureteral Access Sheath</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:48:37.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374024396</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-Flex Ureteral Access Sheath</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:47:08.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374024389</udiDi>
    <basicUdiDi>081226101UAS012SH</basicUdiDi>
    <tradeName>U-Flex Ureteral Access Sheath</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:47:07.464Z</lastUpdated>
  </row>
</eudamedExport>