<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>18699415702006</udiDi>
    <basicUdiDi>B-18699415702006</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Female 20 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>MYFA 2012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:58.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>18699415701993</udiDi>
    <basicUdiDi>B-18699415701993</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Male 40 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>MYMA 4018</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:54.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>18699415701986</udiDi>
    <basicUdiDi>B-18699415701986</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Male 40 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>MYMA 4016</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:53.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>18699415701979</udiDi>
    <basicUdiDi>B-18699415701979</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Male 40 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>MYMA 4014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:52.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>18699415701962</udiDi>
    <basicUdiDi>B-18699415701962</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Male 40 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>MYMA 4012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:52.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>18699415701955</udiDi>
    <basicUdiDi>B-18699415701955</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Male 40 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>MYMA 4010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:48.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>18699415701948</udiDi>
    <basicUdiDi>B-18699415701948</basicUdiDi>
    <tradeName>MIYACATH</tradeName>
    <deviceName>MIYACATH Antibacterial Hydrophilic Urinary Catheter Male 40 CM 08 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>MYMA 4008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:49:47.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934602399</udiDi>
    <basicUdiDi>B-16945934602399</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-14 middle box</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T15:44:25.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602392</udiDi>
    <basicUdiDi>B-06945934602392</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-14</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T03:55:34.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675359755</udiDi>
    <basicUdiDi>B-06970675359755</basicUdiDi>
    <tradeName>06970675359755</tradeName>
    <deviceName>Hydrophilic Nelaton 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHF12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:00:13.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675359748</udiDi>
    <basicUdiDi>B-06970675359748</basicUdiDi>
    <tradeName>06970675359748</tradeName>
    <deviceName>Hydrophilic Nelaton 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHF10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:00:13.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357058</udiDi>
    <basicUdiDi>B-06970675357058</basicUdiDi>
    <tradeName>06970675357058</tradeName>
    <deviceName>Hydrophilic Nelaton 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHM16T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:57.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357041</udiDi>
    <basicUdiDi>B-06970675357041</basicUdiDi>
    <tradeName>06970675357041</tradeName>
    <deviceName>Hydrophilic Nelaton 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHM14T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:57.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357034</udiDi>
    <basicUdiDi>B-06970675357034</basicUdiDi>
    <tradeName>06970675357034</tradeName>
    <deviceName>Hydrophilic Nelaton 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHM12T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:56.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675357027</udiDi>
    <basicUdiDi>B-06970675357027</basicUdiDi>
    <tradeName>06970675357027</tradeName>
    <deviceName>Hydrophilic Nelaton 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHM10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:55.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675356679</udiDi>
    <basicUdiDi>B-06970675356679</basicUdiDi>
    <tradeName>06970675356679</tradeName>
    <deviceName>Smili-cath</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCS18M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:51.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675356662</udiDi>
    <basicUdiDi>B-06970675356662</basicUdiDi>
    <tradeName>06970675356662</tradeName>
    <deviceName>Smili-cath</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCS16M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:50.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675356655</udiDi>
    <basicUdiDi>B-06970675356655</basicUdiDi>
    <tradeName>06970675356655</tradeName>
    <deviceName>Smili-cath</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCS14M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:49.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675356648</udiDi>
    <basicUdiDi>B-06970675356648</basicUdiDi>
    <tradeName>06970675356648</tradeName>
    <deviceName>Smili-cath</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCS12M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:49.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970675356631</udiDi>
    <basicUdiDi>B-06970675356631</basicUdiDi>
    <tradeName>06970675356631</tradeName>
    <deviceName>Smili-cath</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCS10M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:59:45.008Z</lastUpdated>
  </row>
</eudamedExport>