<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806367004123</udiDi>
    <basicUdiDi>B-08806367004123</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Esophageal 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>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HES-18-060-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:05.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367004116</udiDi>
    <basicUdiDi>B-08806367004116</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Esophageal 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>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HES-18-050-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:04.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103900</udiDi>
    <basicUdiDi>B-08800038103900</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP201707</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:42.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103894</udiDi>
    <basicUdiDi>B-08800038103894</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP201507</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:42.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103887</udiDi>
    <basicUdiDi>B-08800038103887</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP201307</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:41.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103870</udiDi>
    <basicUdiDi>B-08800038103870</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP201107</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:37.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103863</udiDi>
    <basicUdiDi>B-08800038103863</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP200907</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:36.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103856</udiDi>
    <basicUdiDi>B-08800038103856</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP181707</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:35.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103849</udiDi>
    <basicUdiDi>B-08800038103849</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP181507</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:34.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103818</udiDi>
    <basicUdiDi>B-08800038103818</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP180907</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:30.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103801</udiDi>
    <basicUdiDi>B-08800038103801</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP201707</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:30.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103832</udiDi>
    <basicUdiDi>B-08800038103832</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP181307</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:29.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103825</udiDi>
    <basicUdiDi>B-08800038103825</basicUdiDi>
    <tradeName>EGIS Esophageal e-PTFE Covered Partial Stent</tradeName>
    <deviceName>EGIS Esophageal e-PTFE Covered Partial Stent</deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEP181107</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:28.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103795</udiDi>
    <basicUdiDi>B-08800038103795</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP201507</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:11.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103788</udiDi>
    <basicUdiDi>B-08800038103788</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP201307</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:10.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103771</udiDi>
    <basicUdiDi>B-08800038103771</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP201107</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:09.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103764</udiDi>
    <basicUdiDi>B-08800038103764</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP200907</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:09.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103757</udiDi>
    <basicUdiDi>B-08800038103757</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP181707</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:05.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103740</udiDi>
    <basicUdiDi>B-08800038103740</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP181507</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:04.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038103733</udiDi>
    <basicUdiDi>B-08800038103733</basicUdiDi>
    <tradeName>EGIS Esophageal Silicone Covered Partial Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P050199</emdnCode>
    <emdnDescription>ESOPHAGEAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP181307</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:10:03.542Z</lastUpdated>
  </row>
</eudamedExport>