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<eudamedExport entity="devices">
  <row>
    <udiDi>08809233102398</udiDi>
    <basicUdiDi>B-08809233102398</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS0807B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102404</udiDi>
    <basicUdiDi>B-08809233102404</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS0808B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102411</udiDi>
    <basicUdiDi>B-08809233102411</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS0809B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102428</udiDi>
    <basicUdiDi>B-08809233102428</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS0810B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102442</udiDi>
    <basicUdiDi>B-08809233102442</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS0812B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102473</udiDi>
    <basicUdiDi>B-08809233102473</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1004B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102480</udiDi>
    <basicUdiDi>B-08809233102480</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1005B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102497</udiDi>
    <basicUdiDi>B-08809233102497</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1006B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102503</udiDi>
    <basicUdiDi>B-08809233102503</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1007B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102510</udiDi>
    <basicUdiDi>B-08809233102510</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1008B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102527</udiDi>
    <basicUdiDi>B-08809233102527</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1009B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102534</udiDi>
    <basicUdiDi>B-08809233102534</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1010B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102558</udiDi>
    <basicUdiDi>B-08809233102558</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Both Bare-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>BS1012B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102565</udiDi>
    <basicUdiDi>B-08809233102565</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0604F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102589</udiDi>
    <basicUdiDi>B-08809233102589</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0804F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102596</udiDi>
    <basicUdiDi>B-08809233102596</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0805F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102602</udiDi>
    <basicUdiDi>B-08809233102602</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0806F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102619</udiDi>
    <basicUdiDi>B-08809233102619</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0807F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102626</udiDi>
    <basicUdiDi>B-08809233102626</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0808F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809233102633</udiDi>
    <basicUdiDi>B-08809233102633</basicUdiDi>
    <tradeName>ComVi Biliary 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>BC0809F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:55:19.201Z</lastUpdated>
  </row>
</eudamedExport>