<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809643753500</udiDi>
    <basicUdiDi>B-08809643753500</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD0809-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753517</udiDi>
    <basicUdiDi>B-08809643753517</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD0810-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753524</udiDi>
    <basicUdiDi>B-08809643753524</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD0812-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753531</udiDi>
    <basicUdiDi>B-08809643753531</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD1005-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753548</udiDi>
    <basicUdiDi>B-08809643753548</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD1007-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753555</udiDi>
    <basicUdiDi>B-08809643753555</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD1008-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753562</udiDi>
    <basicUdiDi>B-08809643753562</basicUdiDi>
    <tradeName>Niti-S Biliary Uncovered Stent [LCD-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD1009-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753579</udiDi>
    <basicUdiDi>B-08809643753579</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0603F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753586</udiDi>
    <basicUdiDi>B-08809643753586</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0804FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753593</udiDi>
    <basicUdiDi>B-08809643753593</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0805FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753609</udiDi>
    <basicUdiDi>B-08809643753609</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0807FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753616</udiDi>
    <basicUdiDi>B-08809643753616</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0809FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753623</udiDi>
    <basicUdiDi>B-08809643753623</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0812FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753630</udiDi>
    <basicUdiDi>B-08809643753630</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS1004FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753647</udiDi>
    <basicUdiDi>B-08809643753647</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS1005FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753654</udiDi>
    <basicUdiDi>B-08809643753654</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS1009FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753661</udiDi>
    <basicUdiDi>B-08809643753661</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Full Covered-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS1012FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753678</udiDi>
    <basicUdiDi>B-08809643753678</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0805FWS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753685</udiDi>
    <basicUdiDi>B-08809643753685</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0807FWS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809643753692</udiDi>
    <basicUdiDi>B-08809643753692</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS0808FWS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:44:51.461Z</lastUpdated>
  </row>
</eudamedExport>