<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806367049728</udiDi>
    <basicUdiDi>B-08806367049728</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD-20-090-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:44:02.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367049711</udiDi>
    <basicUdiDi>B-08806367049711</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD-20-080-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:43:57.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367049698</udiDi>
    <basicUdiDi>B-08806367049698</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD-20-060-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:43:56.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367049452</udiDi>
    <basicUdiDi>B-08806367049452</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD-20-060-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:43:55.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046109</udiDi>
    <basicUdiDi>B-08806367046109</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN24150-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:54.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046086</udiDi>
    <basicUdiDi>B-08806367046086</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN24050-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:53.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046079</udiDi>
    <basicUdiDi>B-08806367046079</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN22110-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:51.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046062</udiDi>
    <basicUdiDi>B-08806367046062</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN22100-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:49.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046055</udiDi>
    <basicUdiDi>B-08806367046055</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN22080-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:47.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046048</udiDi>
    <basicUdiDi>B-08806367046048</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN22060-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:46.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367046031</udiDi>
    <basicUdiDi>B-08806367046031</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCN22050-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:41:44.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367039699</udiDi>
    <basicUdiDi>B-08806367039699</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCB24060-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:37:53.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367039675</udiDi>
    <basicUdiDi>B-08806367039675</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCB24120-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:37:49.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367039668</udiDi>
    <basicUdiDi>B-08806367039668</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCB24090-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:37:48.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367039538</udiDi>
    <basicUdiDi>B-08806367039538</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCB24160-Z070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:37:20.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367038357</udiDi>
    <basicUdiDi>B-08806367038357</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Colon/Rectum Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNZ-22-130-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:36:58.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367034519</udiDi>
    <basicUdiDi>B-08806367034519</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDCL-20-080-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:35:38.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367032775</udiDi>
    <basicUdiDi>B-08806367032775</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDCL-20-100-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:35:13.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367032591</udiDi>
    <basicUdiDi>B-08806367032591</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDCL-20-160-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:35:13.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367032584</udiDi>
    <basicUdiDi>B-08806367032584</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Duodenal Pyloric Stent with Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDCL-20-140-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:35:11.402Z</lastUpdated>
  </row>
</eudamedExport>