<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809293834574</udiDi>
    <basicUdiDi>B-08809293834574</basicUdiDi>
    <tradeName>ComVi Pyloric/Duodenal Stent [Both Bare-Type]</tradeName>
    <deviceName>ComVi Pyloric/Duodenal 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>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT2006BA-22</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:30:04.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834543</udiDi>
    <basicUdiDi>B-08809293834543</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>ESP1608FN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:30:03.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834529</udiDi>
    <basicUdiDi>B-08809293834529</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>TK0812CW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:30:02.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834505</udiDi>
    <basicUdiDi>B-08809293834505</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>TS0810FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:58.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834499</udiDi>
    <basicUdiDi>B-08809293834499</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>TS0808FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:57.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834482</udiDi>
    <basicUdiDi>B-08809293834482</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>TS0608FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:57.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834475</udiDi>
    <basicUdiDi>B-08809293834475</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>BSM1010F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:56.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834468</udiDi>
    <basicUdiDi>B-08809293834468</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>TK1006CWS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:52.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834437</udiDi>
    <basicUdiDi>B-08809293834437</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>BSM0808B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:51.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834420</udiDi>
    <basicUdiDi>B-08809293834420</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>TLD0809</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:50.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834413</udiDi>
    <basicUdiDi>B-08809293834413</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>BCM1009F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:49.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834406</udiDi>
    <basicUdiDi>B-08809293834406</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>BCM1012F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:45.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834390</udiDi>
    <basicUdiDi>B-08809293834390</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>BCM1010F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:45.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834383</udiDi>
    <basicUdiDi>B-08809293834383</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>BCM1008F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:44.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834376</udiDi>
    <basicUdiDi>B-08809293834376</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>BCM1006F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:43.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834369</udiDi>
    <basicUdiDi>B-08809293834369</basicUdiDi>
    <tradeName>Niti-S Esophageal Covered Stent [Beta-2]</tradeName>
    <deviceName>Niti-S Esophageal Covered Stent [Beta-2]</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>EK2618FNT2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:39.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834352</udiDi>
    <basicUdiDi>B-08809293834352</basicUdiDi>
    <tradeName>Niti-S Esophageal Covered Stent [Beta-2]</tradeName>
    <deviceName>Niti-S Esophageal Covered Stent [Beta-2]</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>EK2018FNT2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:38.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834260</udiDi>
    <basicUdiDi>B-08809293834260</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>ES1415FN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:37.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834253</udiDi>
    <basicUdiDi>B-08809293834253</basicUdiDi>
    <tradeName>ComVi Biliary Stent [Both Bare-Type]</tradeName>
    <deviceName>ComVi Biliary 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>TC0609B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:29:37.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809293834246</udiDi>
    <basicUdiDi>B-08809293834246</basicUdiDi>
    <tradeName>ComVi Biliary Stent [Both Bare-Type]</tradeName>
    <deviceName>ComVi Biliary 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>TC0605B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:28:03.623Z</lastUpdated>
  </row>
</eudamedExport>