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<eudamedExport entity="devices">
  <row>
    <udiDi>08905516041900</udiDi>
    <basicUdiDi>890551617TA</basicUdiDi>
    <tradeName>08905516041900</tradeName>
    <deviceName>Suprapubic Catheter Kit</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCSC2208025</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:01.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516041801</udiDi>
    <basicUdiDi>890551616T8</basicUdiDi>
    <tradeName>08905516041801</tradeName>
    <deviceName>Suprapubic Catheter</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCSC0208025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:18:00.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516031512</udiDi>
    <basicUdiDi>890551615T6</basicUdiDi>
    <tradeName>08905516031512</tradeName>
    <deviceName>PCN Catheter Kit / 
Nephrostomy Catheter Kit</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCPC2506030</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:59.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905516015499</udiDi>
    <basicUdiDi>890551614T4</basicUdiDi>
    <tradeName>08905516015499</tradeName>
    <deviceName>PCN Catheter / 
Nephrostomy Catheter</deviceName>
    <manufacturerName>Biorad Medisys Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000013050</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUUF121040</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:55.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675351957</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName>Silicone Foley Catheter</deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC26230D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:50.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>16955824086185</udiDi>
    <basicUdiDi>69558240CS0400100US00016R</basicUdiDi>
    <tradeName>HEKURA URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Conod Medical Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000012600</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UZ6612</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:43:10.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881149429</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName>Latex Foley Catheter</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A101607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:42.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816652530</udiDi>
    <basicUdiDi>69449327FF01B09EN</basicUdiDi>
    <tradeName>All Silicone Foley Catheter</tradeName>
    <deviceName>All Silicone Foley Catheter</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AWB618</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:10.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816626982</udiDi>
    <basicUdiDi>69449327FF01B00E4</basicUdiDi>
    <tradeName>All Silicone Foley Catheter</tradeName>
    <deviceName>All Silicone Foley Catheter</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW6112</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:57.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816626951</udiDi>
    <basicUdiDi>69449327FF01B01E6</basicUdiDi>
    <tradeName>All Silicone Foley Catheter</tradeName>
    <deviceName>All Silicone Foley Catheter</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW6106</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:56.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251320</udiDi>
    <basicUdiDi>622300425SFC3007SP</basicUdiDi>
    <tradeName>ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 6 FG / 2-WAY</tradeName>
    <deviceName>ULTRAMED SILICONE FOLEY BALLOON CATHETER</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3007-6/2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:30:45.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>04034393325842</udiDi>
    <basicUdiDi>4034393CPTURI2B5G</basicUdiDi>
    <tradeName>Katheter Set</tradeName>
    <deviceName>Katheter Set</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66821639-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:26:56.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098800044</udiDi>
    <basicUdiDi>04250098810030EB</basicUdiDi>
    <tradeName>UROMED Transurethral Silicone Balloon Catheter</tradeName>
    <deviceName>TBC01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090.18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:37:32.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098800013</udiDi>
    <basicUdiDi>04250098810030EB</basicUdiDi>
    <tradeName>UROMED Transurethral Silicone Balloon Catheter</tradeName>
    <deviceName>TBC01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090.16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:16.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357119</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC06201DP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:17.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357126</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC08203DP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:17.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357133</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC10203DP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:17.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357225</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC12210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:17.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357232</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC14210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:17.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357249</udiDi>
    <basicUdiDi>697067535IMP2BSNNNSFC00VE</basicUdiDi>
    <tradeName>bio-UMAXX 100% SILIKON FOLEY KATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Integral Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009217</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC16210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.939Z</lastUpdated>
  </row>
</eudamedExport>