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<eudamedExport entity="devices">
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    <udiDi>05907996838943</udiDi>
    <basicUdiDi>B-05907996838943</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFNL-2D-16-30-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:46.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838790</udiDi>
    <basicUdiDi>B-05907996838790</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFNL-2D-18-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:45.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838707</udiDi>
    <basicUdiDi>B-05907996838707</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFNL-2D-12-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:28.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838677</udiDi>
    <basicUdiDi>B-05907996838677</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFNL-2D-10-05-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:27.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838646</udiDi>
    <basicUdiDi>B-05907996838646</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFNL-2D-08-05-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:26.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838615</udiDi>
    <basicUdiDi>B-05907996838615</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFNL-2D-06-03-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:25.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060419220876</udiDi>
    <basicUdiDi>B-05060419220876</basicUdiDi>
    <tradeName>Wycath</tradeName>
    <deviceName>Intermittent and Short Term Use Catheters</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP06</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:52:03.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060419220791</udiDi>
    <basicUdiDi>B-05060419220791</basicUdiDi>
    <tradeName>Wycath</tradeName>
    <deviceName>Intermittent and Short Term Use Catheters</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U4SM10</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:52:02.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060419220784</udiDi>
    <basicUdiDi>B-05060419220784</basicUdiDi>
    <tradeName>Wycath</tradeName>
    <deviceName>Intermittent and Short Term Use Catheters</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U4SM16</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:52:01.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060419220777</udiDi>
    <basicUdiDi>B-05060419220777</basicUdiDi>
    <tradeName>Wycath</tradeName>
    <deviceName>Intermittent and Short Term Use Catheters</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U4SM14</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:52:00.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060419220760</udiDi>
    <basicUdiDi>B-05060419220760</basicUdiDi>
    <tradeName>Wycath</tradeName>
    <deviceName>Intermittent and Short Term Use Catheters</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U4SM12</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:51:56.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052547</udiDi>
    <basicUdiDi>B-06948097052547</basicUdiDi>
    <tradeName>06948097052547</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:08.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104065</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-08PMU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104072</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-10PMU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104089</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-12PMU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104096</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-06PFU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104102</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-08PFU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104119</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-10PFU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104126</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-12PFU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942214104133</udiDi>
    <basicUdiDi>697197678DXACE0107VQ</basicUdiDi>
    <tradeName>Disposable Intermittent Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Daxan Innovative Medical Tech.Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H09-08MU</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-27T10:49:43.022Z</lastUpdated>
  </row>
</eudamedExport>