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<eudamedExport entity="devices">
  <row>
    <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>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>
  <row>
    <udiDi>06970675357256</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>FC18210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357263</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>FC20210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357270</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>FC22210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357287</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>FC24210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357294</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>FC26210D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357386</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>FC16230D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357393</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>FC18230D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357409</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>FC20230D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T04:18:16.274Z</lastUpdated>
  </row>
</eudamedExport>