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    <basicUdiDi>B-08806367016003</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>NESC-18-120-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:42.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367015983</udiDi>
    <basicUdiDi>B-08806367015983</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>NESC-18-100-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:41.667Z</lastUpdated>
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  <row>
    <udiDi>08806367015945</udiDi>
    <basicUdiDi>B-08806367015945</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>NESC-18-060-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:40.853Z</lastUpdated>
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    <udiDi>08806367015815</udiDi>
    <basicUdiDi>B-08806367015815</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>NES-18-120-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:40.051Z</lastUpdated>
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  <row>
    <udiDi>08806367015204</udiDi>
    <basicUdiDi>B-08806367015204</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>NESA-18-100-P070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:24.791Z</lastUpdated>
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  <row>
    <udiDi>08806367004239</udiDi>
    <basicUdiDi>B-08806367004239</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-18-180-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:13.592Z</lastUpdated>
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  <row>
    <udiDi>08806367004222</udiDi>
    <basicUdiDi>B-08806367004222</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-18-170-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:12.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367004192</udiDi>
    <basicUdiDi>B-08806367004192</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-18-140-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:11.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367004178</udiDi>
    <basicUdiDi>B-08806367004178</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-18-120-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:11.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367004161</udiDi>
    <basicUdiDi>B-08806367004161</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-18-110-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:07.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367004130</udiDi>
    <basicUdiDi>B-08806367004130</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-18-080-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:27:06.373Z</lastUpdated>
  </row>
  <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>
</eudamedExport>