<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809643754804</udiDi>
    <basicUdiDi>B-08809643754804</basicUdiDi>
    <tradeName>ComVi Biliary Stent [Full Covered-Type]</tradeName>
    <deviceName>ComVi Biliary 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>BCM0606F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:27:03.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754798</udiDi>
    <basicUdiDi>B-08809643754798</basicUdiDi>
    <tradeName>ComVi Biliary Stent [Full Covered-Type]</tradeName>
    <deviceName>ComVi Biliary 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>BCM0605F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:27:02.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754781</udiDi>
    <basicUdiDi>B-08809643754781</basicUdiDi>
    <tradeName>ComVi Biliary Stent [Full Covered-Type]</tradeName>
    <deviceName>ComVi Biliary 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>BCM0604F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:27:01.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754774</udiDi>
    <basicUdiDi>B-08809643754774</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM1009B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:27:01.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754767</udiDi>
    <basicUdiDi>B-08809643754767</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM1005B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:56.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754750</udiDi>
    <basicUdiDi>B-08809643754750</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0810B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:55.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754743</udiDi>
    <basicUdiDi>B-08809643754743</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0809B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:54.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754736</udiDi>
    <basicUdiDi>B-08809643754736</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0807B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:53.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754729</udiDi>
    <basicUdiDi>B-08809643754729</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0806B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:49.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754712</udiDi>
    <basicUdiDi>B-08809643754712</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0805B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:49.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754705</udiDi>
    <basicUdiDi>B-08809643754705</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0610B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:48.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754699</udiDi>
    <basicUdiDi>B-08809643754699</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0609B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:47.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754651</udiDi>
    <basicUdiDi>B-08809643754651</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0605B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:43.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754682</udiDi>
    <basicUdiDi>B-08809643754682</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0608B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:41.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754675</udiDi>
    <basicUdiDi>B-08809643754675</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0607B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:41.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754668</udiDi>
    <basicUdiDi>B-08809643754668</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Both 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>BSM0606B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:40.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754644</udiDi>
    <basicUdiDi>B-08809643754644</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>BSM0809F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:23.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754637</udiDi>
    <basicUdiDi>B-08809643754637</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>BSM0807F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:22.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754620</udiDi>
    <basicUdiDi>B-08809643754620</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>BSM0805F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:21.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643754613</udiDi>
    <basicUdiDi>B-08809643754613</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>BSM0803F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:26:21.078Z</lastUpdated>
  </row>
</eudamedExport>