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<eudamedExport entity="devices">
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    <udiDi>08809482277229</udiDi>
    <basicUdiDi>B-08809482277229</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [LCD-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>TLD1006-7</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:20.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482277212</udiDi>
    <basicUdiDi>B-08809482277212</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [LCD-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>TLD1004-7</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:20.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482277205</udiDi>
    <basicUdiDi>B-08809482277205</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [LCD-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>BLD1005-7</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:17.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482277151</udiDi>
    <basicUdiDi>B-08809482277151</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [LCD-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>TLD0804-7</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:15.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482277144</udiDi>
    <basicUdiDi>B-08809482277144</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>BSM0806FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:13.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482277137</udiDi>
    <basicUdiDi>B-08809482277137</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>BSM0808FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:13.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482277090</udiDi>
    <basicUdiDi>B-08809482277090</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>TS0806FWS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:11.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274884</udiDi>
    <basicUdiDi>B-08809482274884</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>BSM1010FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:09.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274877</udiDi>
    <basicUdiDi>B-08809482274877</basicUdiDi>
    <tradeName>ComVi Pyloric/Duodenal Stent [Flare-Type]</tradeName>
    <deviceName>ComVi Pyloric/Duodenal 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>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT2606P</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:07.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274853</udiDi>
    <basicUdiDi>B-08809482274853</basicUdiDi>
    <tradeName>ComVi Pyloric/Duodenal Stent [Flare-Type]</tradeName>
    <deviceName>ComVi Pyloric/Duodenal 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>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT2210P-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:06.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274846</udiDi>
    <basicUdiDi>B-08809482274846</basicUdiDi>
    <tradeName>ComVi Pyloric/Duodenal Stent [Flare-Type]</tradeName>
    <deviceName>ComVi Pyloric/Duodenal 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>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT2208P-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:05.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274839</udiDi>
    <basicUdiDi>B-08809482274839</basicUdiDi>
    <tradeName>ComVi Pyloric/Duodenal Stent [Flare-Type]</tradeName>
    <deviceName>ComVi Pyloric/Duodenal 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>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT2212P-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:02.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274778</udiDi>
    <basicUdiDi>B-08809482274778</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [M-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [M-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>TN0806</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:01.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274761</udiDi>
    <basicUdiDi>B-08809482274761</basicUdiDi>
    <tradeName>ComVi Biliary Stent [End Bare-Type]</tradeName>
    <deviceName>ComVi Biliary Stent [End Bare-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>BC1007H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:03:00.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274754</udiDi>
    <basicUdiDi>B-08809482274754</basicUdiDi>
    <tradeName>ComVi Biliary Stent [End Bare-Type]</tradeName>
    <deviceName>ComVi Biliary Stent [End Bare-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>TC0807H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:02:58.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274709</udiDi>
    <basicUdiDi>B-08809482274709</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [M-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [M-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>TN0812</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:02:56.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274662</udiDi>
    <basicUdiDi>B-08809482274662</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</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>TK1005CWS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:02:54.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274655</udiDi>
    <basicUdiDi>B-08809482274655</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</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>TK0812CWS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:02:53.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274648</udiDi>
    <basicUdiDi>B-08809482274648</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</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>TK0805CWS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:02:52.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809482274631</udiDi>
    <basicUdiDi>B-08809482274631</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</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>TK0804CWS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:02:49.827Z</lastUpdated>
  </row>
</eudamedExport>