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<eudamedExport entity="devices">
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    <udiDi>06941513223217</udiDi>
    <basicUdiDi>697005757111HE</basicUdiDi>
    <tradeName>Ureteral Access Sheathes</tradeName>
    <deviceName>Ureteral Access Sheathes</deviceName>
    <manufacturerName>Jiangsu Vedkang Medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008462</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>VDK-NSA-10350A-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:05:16.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>03600040975312</udiDi>
    <basicUdiDi>57089326358428G</basicUdiDi>
    <tradeName>Coloplast</tradeName>
    <deviceName>Ureteral dilator</deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBD010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:49:50.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>03600040975343</udiDi>
    <basicUdiDi>57089326358428G</basicUdiDi>
    <tradeName>Coloplast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBD014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:38:11.165Z</lastUpdated>
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  <row>
    <udiDi>D-6979246722GD</udiDi>
    <basicUdiDi>B-6979246722GD</basicUdiDi>
    <tradeName>Disposable Ureteral Access Sheaths</tradeName>
    <deviceName>Disposable Ureteral Access Sheaths</deviceName>
    <manufacturerName>Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027760</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:57.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964001697800</udiDi>
    <basicUdiDi>89640016976485085U2</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 11 Y 12</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485085</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:54:12.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002178427</udiDi>
    <basicUdiDi>0827002CINC050-124_BJA</basicUdiDi>
    <tradeName>Urethral Dilation Balloon Catheter With Coudé Tip</tradeName>
    <deviceName>Urethral Dilation Balloon Catheter</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDBS-090029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:31.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002173101</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Ureteral Dilator Set Dilators With AQ® Hydrophilic Coating</tradeName>
    <deviceName>Ureteral Dilator [With AQ® Hydrophilic Coating With Modified Taper; Set Dilators With AQ® Hydrophilic Coating; S~Curve® with AQ® Hydrophilic Coating]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ-076000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:30.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002142619</udiDi>
    <basicUdiDi>0827002CINC050-124_B1YT</basicUdiDi>
    <tradeName>Balloon Ureteral Dilator</tradeName>
    <deviceName>Balloon Ureteral Dilator [Set]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:09.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002141858</udiDi>
    <basicUdiDi>0827002CINC050-124_A2YS</basicUdiDi>
    <tradeName>Urethral Dilator Set</tradeName>
    <deviceName>Dilator Set [Ureteral; Integral Filiform; Urethral; Tunner Pediatric Urethral]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:05.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261014968</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>UF14/12-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:47.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261012605</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>ARMADA Dilators &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>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NOT6/10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:40.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261012582</udiDi>
    <basicUdiDi>081226101BDR009KX</basicUdiDi>
    <tradeName>UreTrack Ureteral Balloon Dilator</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UBD5/4</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:36.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729429920</udiDi>
    <basicUdiDi>01915060000000000000540N5</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator UAS Family</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>M0062502000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:32.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729341109</udiDi>
    <basicUdiDi>01915060000000000000532N6</basicUdiDi>
    <tradeName>UroMax Ultra™</tradeName>
    <deviceName>UroMax Ultra Balloon Dilation Catheter</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>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062251000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:27.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729005421</udiDi>
    <basicUdiDi>01915060000000000000516N8</basicUdiDi>
    <tradeName>08714729005421</tradeName>
    <deviceName>Renal Dilators  &amp;  Renal Sheath</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>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062601000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:07:41.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729005322</udiDi>
    <basicUdiDi>01915060000000000000603N4</basicUdiDi>
    <tradeName>08714729005322</tradeName>
    <deviceName>URETERAL DILATORS</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>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0062401000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:07:40.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000000767725176V8</udiDi>
    <basicUdiDi>B-ESMF000000767725176V8</basicUdiDi>
    <tradeName>Glycocolle 1,5% Grifols</tradeName>
    <deviceName>Glycocolle 1,5% Grifols</deviceName>
    <manufacturerName>Laboratorios Grifols S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000767</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0380</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725176</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:52:31.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000000767725175V6</udiDi>
    <basicUdiDi>B-ESMF000000767725175V6</basicUdiDi>
    <tradeName>Sérum physiologique pour irrigation Grifols</tradeName>
    <deviceName>Sérum physiologique pour irrigation Grifols</deviceName>
    <manufacturerName>Laboratorios Grifols S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000767</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0380</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725175</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:52:30.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000000767725174V4</udiDi>
    <basicUdiDi>B-ESMF000000767725174V4</basicUdiDi>
    <tradeName>Eau pour irrigation Grifols</tradeName>
    <deviceName>Eau pour irrigation Grifols</deviceName>
    <manufacturerName>Laboratorios Grifols S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000767</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0380</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725174</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:52:26.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000000767725062UQ</udiDi>
    <basicUdiDi>B-ESMF000000767725062UQ</basicUdiDi>
    <tradeName>Glicina al 1,5% Grifols</tradeName>
    <deviceName>Glicina al 1,5% Grifols</deviceName>
    <manufacturerName>Laboratorios Grifols S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000767</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0380</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>725062</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:52:26.004Z</lastUpdated>
  </row>
</eudamedExport>