<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07333387047430</udiDi>
    <basicUdiDi>733338724104D3</basicUdiDi>
    <tradeName>Navina Mini Set</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6930730</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:35.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>16955824049609</udiDi>
    <basicUdiDi>69558240CW0100000EB0005TR</basicUdiDi>
    <tradeName>EINLAUFBEUTEL</tradeName>
    <deviceName>Enema irrigation bag</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020102</emdnCode>
    <emdnDescription>INTESTINAL LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I6 35000-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:43:05.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>16955824045014</udiDi>
    <basicUdiDi>69558240CW0100000EB0003TM</basicUdiDi>
    <tradeName>Kit de lavement à usage unique</tradeName>
    <deviceName>Enema kit</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020102</emdnCode>
    <emdnDescription>INTESTINAL LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-CONEM02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:42:46.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926767200849</udiDi>
    <basicUdiDi>69267672003XD</basicUdiDi>
    <tradeName>06926767200849</tradeName>
    <deviceName>Nasogastric Feeding Tubes</deviceName>
    <manufacturerName>Shandong Steve Medical Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034622</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WG-Fr8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:31.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260319210330</udiDi>
    <basicUdiDi>426031921000colon6H</basicUdiDi>
    <tradeName>HUMACOLON Darmrohr DR13</tradeName>
    <deviceName>HUMACOLON Darmrohr DR13</deviceName>
    <manufacturerName>Hänsler Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:51:45.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260319210224</udiDi>
    <basicUdiDi>426031921000DarmbeutelDQ</basicUdiDi>
    <tradeName>OZONOSAN Reservoir Bag 1.5 L</tradeName>
    <deviceName>OZONOSAN Reservoir Bag 1.5 L</deviceName>
    <manufacturerName>Hänsler Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:51:41.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260319210217</udiDi>
    <basicUdiDi>426031921000Darmset3N</basicUdiDi>
    <tradeName>OZONOSAN Rectal Insufflation Set</tradeName>
    <deviceName>OZONOSAN Rectal Insufflation Set</deviceName>
    <manufacturerName>Hänsler Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000031904</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:51:41.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260319210149</udiDi>
    <basicUdiDi>426031921000DosierbalgM6</basicUdiDi>
    <tradeName>OZONOSAN Dosing Bellows</tradeName>
    <deviceName>OZONOSAN Dosing Bellows</deviceName>
    <manufacturerName>Hänsler Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:51:39.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260319210132</udiDi>
    <basicUdiDi>426031921000Katheter2D</basicUdiDi>
    <tradeName>OZONOSAN Catheter 18 Ch.</tradeName>
    <deviceName>OZONOSAN Catheter 18 Ch.</deviceName>
    <manufacturerName>Hänsler Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:51:35.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203200899</udiDi>
    <basicUdiDi>42502032PRI0024C</basicUdiDi>
    <tradeName>Pri-Colobag Irrigationssystem mit Ballondarmrohr</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20690</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:52:33.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>04037566000003</udiDi>
    <basicUdiDi>40375662000LZ</basicUdiDi>
    <tradeName>Irrigator-Set</tradeName>
    <deviceName>Rectal Syringe, Vaginal Douche</deviceName>
    <manufacturerName>Albert Hohlkörper GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005482</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020102</emdnCode>
    <emdnDescription>INTESTINAL LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S 60 006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:28:46.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057009</udiDi>
    <basicUdiDi>B-06948097057009</basicUdiDi>
    <tradeName>06948097057009</tradeName>
    <deviceName>Stomach Tubes for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6Fr</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934605014</udiDi>
    <basicUdiDi>B-26945934605014</basicUdiDi>
    <tradeName>Stomach tube FR20</tradeName>
    <deviceName>Stomach tube FR20</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:55.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934605007</udiDi>
    <basicUdiDi>B-26945934605007</basicUdiDi>
    <tradeName>Stomach tube FR18</tradeName>
    <deviceName>Stomach tube FR18</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-18</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:54.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934603270</udiDi>
    <basicUdiDi>B-26945934603270</basicUdiDi>
    <tradeName>Stomach tube FR16</tradeName>
    <deviceName>Stomach tube FR16</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-16</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:54.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934603263</udiDi>
    <basicUdiDi>B-26945934603263</basicUdiDi>
    <tradeName>Stomach tube FR14</tradeName>
    <deviceName>Stomach tube FR14</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-16</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:53.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934605017</udiDi>
    <basicUdiDi>B-16945934605017</basicUdiDi>
    <tradeName>Stomach tube FR20</tradeName>
    <deviceName>Stomach tube FR20</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:24:13.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934605000</udiDi>
    <basicUdiDi>B-16945934605000</basicUdiDi>
    <tradeName>Stomach tube FR18</tradeName>
    <deviceName>Stomach tube FR18</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-18</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:24:12.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934603273</udiDi>
    <basicUdiDi>B-16945934603273</basicUdiDi>
    <tradeName>Stomach tube FR16</tradeName>
    <deviceName>Stomach tube FR16</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-16</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:24:11.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934603266</udiDi>
    <basicUdiDi>B-16945934603266</basicUdiDi>
    <tradeName>Stomach tube FR14</tradeName>
    <deviceName>Stomach tube FR14</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C03-01-14</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:24:10.924Z</lastUpdated>
  </row>
</eudamedExport>