<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>08809643751346</udiDi>
    <basicUdiDi>B-08809643751346</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>TLD1004-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:58.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643751308</udiDi>
    <basicUdiDi>B-08809643751308</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>BN0612-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:58.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643751254</udiDi>
    <basicUdiDi>B-08809643751254</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>BK0608CW2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:57.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750967</udiDi>
    <basicUdiDi>B-08809643750967</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>TLD1006-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:56.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750950</udiDi>
    <basicUdiDi>B-08809643750950</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>TLD0808-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:52.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750943</udiDi>
    <basicUdiDi>B-08809643750943</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>TLD0806-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:51.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750936</udiDi>
    <basicUdiDi>B-08809643750936</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>BLD0606-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:50.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750912</udiDi>
    <basicUdiDi>B-08809643750912</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>BN0610-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:50.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750905</udiDi>
    <basicUdiDi>B-08809643750905</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>BN0608-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:46.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750899</udiDi>
    <basicUdiDi>B-08809643750899</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>BN0606-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:45.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750882</udiDi>
    <basicUdiDi>B-08809643750882</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>BLD0804-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:44.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750813</udiDi>
    <basicUdiDi>B-08809643750813</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>TLD0804-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:43.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750806</udiDi>
    <basicUdiDi>B-08809643750806</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [D-Type]</tradeName>
    <deviceName>Niti-S Biliary Uncovered Stent [D-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>BDM1009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:39.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750738</udiDi>
    <basicUdiDi>B-08809643750738</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Full Covered-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>BSM0804F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:38.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750691</udiDi>
    <basicUdiDi>B-08809643750691</basicUdiDi>
    <tradeName>Niti-S Esophageal Covered Stent [Conio]</tradeName>
    <deviceName>Niti-S Esophageal Covered Stent [Conio]</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESP1815FNR2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:38.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750660</udiDi>
    <basicUdiDi>B-08809643750660</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>PCT2612P-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:19:38.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750646</udiDi>
    <basicUdiDi>B-08809643750646</basicUdiDi>
    <tradeName>Niti-S Esophageal Covered Stent [Conio]</tradeName>
    <deviceName>Niti-S Esophageal Covered Stent [Conio]</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES1815FNR2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:18:09.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750608</udiDi>
    <basicUdiDi>B-08809643750608</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>BC1012H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:18:08.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750585</udiDi>
    <basicUdiDi>B-08809643750585</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>BSM1012FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:18:07.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643750578</udiDi>
    <basicUdiDi>B-08809643750578</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>BSM0612FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:18:04.585Z</lastUpdated>
  </row>
</eudamedExport>