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<eudamedExport entity="devices">
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    <basicUdiDi>B-10704411003618</basicUdiDi>
    <tradeName>AMSure® PVC Intermittent Catheter</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS860608</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:50:41.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411003601</udiDi>
    <basicUdiDi>B-10704411003601</basicUdiDi>
    <tradeName>AMSure® PVC Intermittent Catheter</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS860606</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:50:41.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411003564</udiDi>
    <basicUdiDi>B-10704411003564</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Closed system self-catheterization kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:50:22.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411003557</udiDi>
    <basicUdiDi>B-10704411003557</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Closed system self-catheterization kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:50:22.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001881</udiDi>
    <basicUdiDi>B-10704411001881</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:46:10.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001874</udiDi>
    <basicUdiDi>B-10704411001874</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44026</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:46:09.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001867</udiDi>
    <basicUdiDi>B-10704411001867</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:46:07.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001850</udiDi>
    <basicUdiDi>B-10704411001850</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:46:04.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001843</udiDi>
    <basicUdiDi>B-10704411001843</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:46:03.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001836</udiDi>
    <basicUdiDi>B-10704411001836</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:46:02.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001829</udiDi>
    <basicUdiDi>B-10704411001829</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:45:58.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001812</udiDi>
    <basicUdiDi>B-10704411001812</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:45:57.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001805</udiDi>
    <basicUdiDi>B-10704411001805</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:45:56.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001799</udiDi>
    <basicUdiDi>B-10704411001799</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:45:55.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411001782</udiDi>
    <basicUdiDi>B-10704411001782</basicUdiDi>
    <tradeName>AMSure® RED RUBBER URETHRAL CATHETER</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS44008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:45:51.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699415730873</udiDi>
    <basicUdiDi>B-08699415730873</basicUdiDi>
    <tradeName>HOMECATH</tradeName>
    <deviceName>HOMECATH Nelaton Urinary Catheter Female 15 CM 18 CH</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNCF 1518</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:43:37.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699415730866</udiDi>
    <basicUdiDi>B-08699415730866</basicUdiDi>
    <tradeName>HOMECATH</tradeName>
    <deviceName>HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 16 CH</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNCF 1516</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:43:35.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699415730859</udiDi>
    <basicUdiDi>B-08699415730859</basicUdiDi>
    <tradeName>HOMECATH</tradeName>
    <deviceName>HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 14 CH</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNCF 1514</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:43:32.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699415730835</udiDi>
    <basicUdiDi>B-08699415730835</basicUdiDi>
    <tradeName>HOMECATH</tradeName>
    <deviceName>HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 10 CH 40pcs/box</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNCP 1510</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:43:32.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699415730842</udiDi>
    <basicUdiDi>B-08699415730842</basicUdiDi>
    <tradeName>HOMECATH</tradeName>
    <deviceName>HOMECATH Nelaton Urinary Catheter Female 15 CM 12 CH</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNCF 1512</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:43:30.501Z</lastUpdated>
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</eudamedExport>