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<eudamedExport entity="devices">
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    <udiDi>08809423560298</udiDi>
    <basicUdiDi>B-08809423560298</basicUdiDi>
    <tradeName>HILZO Biliary Uncovered Stent</tradeName>
    <deviceName>HILZO Biliary Uncovered Stent</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV0804</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-24T01:39:39.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423560007</udiDi>
    <basicUdiDi>B-08809423560007</basicUdiDi>
    <tradeName>HILZO Biliary Uncovered Stent</tradeName>
    <deviceName>HILZO Biliary Uncovered Stent</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV1005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-24T01:39:36.734Z</lastUpdated>
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  <row>
    <udiDi>08806367064318</udiDi>
    <basicUdiDi>B-08806367064318</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BNHS-06-080-060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:48:11.299Z</lastUpdated>
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  <row>
    <udiDi>08800038120365</udiDi>
    <basicUdiDi>B-08800038120365</basicUdiDi>
    <tradeName>EGIS Biliary Flared Fully Covered Valve 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FVPC10070</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:54.500Z</lastUpdated>
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  <row>
    <udiDi>08809867550190</udiDi>
    <basicUdiDi>B-08809867550190</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08110-Q060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:16.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550183</udiDi>
    <basicUdiDi>B-08809867550183</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08100-Q060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:14.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550176</udiDi>
    <basicUdiDi>B-08809867550176</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08100-E180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:12.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550169</udiDi>
    <basicUdiDi>B-08809867550169</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08090-E230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:10.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550152</udiDi>
    <basicUdiDi>B-08809867550152</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08080-Q060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:09.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550145</udiDi>
    <basicUdiDi>B-08809867550145</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08080-E180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:07.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550138</udiDi>
    <basicUdiDi>B-08809867550138</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08070-E230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:05.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550121</udiDi>
    <basicUdiDi>B-08809867550121</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08060-Q060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:03.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550114</udiDi>
    <basicUdiDi>B-08809867550114</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08060-E180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:02.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809867550107</udiDi>
    <basicUdiDi>B-08809867550107</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Biliary 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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCA08050-E230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:56:01.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643756273</udiDi>
    <basicUdiDi>B-08809643756273</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM1009FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:29:59.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643756266</udiDi>
    <basicUdiDi>B-08809643756266</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM1007FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:29:58.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643756259</udiDi>
    <basicUdiDi>B-08809643756259</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM1005FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:29:57.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643756242</udiDi>
    <basicUdiDi>B-08809643756242</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM0812FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:29:56.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643756235</udiDi>
    <basicUdiDi>B-08809643756235</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM0810FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:29:52.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643756228</udiDi>
    <basicUdiDi>B-08809643756228</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSM0809FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:29:51.811Z</lastUpdated>
  </row>
</eudamedExport>