<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806369419680</udiDi>
    <basicUdiDi>B-08806369419680</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-080409</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:42:03.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419666</udiDi>
    <basicUdiDi>B-08806369419666</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-080309</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:41:55.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419642</udiDi>
    <basicUdiDi>B-08806369419642</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-080209</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:41:51.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419482</udiDi>
    <basicUdiDi>B-08806369419482</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060809</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:41:28.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419468</udiDi>
    <basicUdiDi>B-08806369419468</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060709</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:41:25.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419444</udiDi>
    <basicUdiDi>B-08806369419444</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060609</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:41:17.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419420</udiDi>
    <basicUdiDi>B-08806369419420</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060509</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:41:13.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419406</udiDi>
    <basicUdiDi>B-08806369419406</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060409</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:50.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419383</udiDi>
    <basicUdiDi>B-08806369419383</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060309</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:46.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369419369</udiDi>
    <basicUdiDi>B-08806369419369</basicUdiDi>
    <tradeName>BONASTENT® Tracheal/Bronchial Covered</tradeName>
    <deviceName>Sterile Single-use Tracheal/Bronchial Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0401</emdnCode>
    <emdnDescription>TRACHEOBRONCHIAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTB-060209</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:42.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412681</udiDi>
    <basicUdiDi>B-08806369412681</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161818</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:38.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412605</udiDi>
    <basicUdiDi>B-08806369412605</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161418</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:10.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412667</udiDi>
    <basicUdiDi>B-08806369412667</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161718</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:06.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412643</udiDi>
    <basicUdiDi>B-08806369412643</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161618</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:40:02.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412629</udiDi>
    <basicUdiDi>B-08806369412629</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161518</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:39:58.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412582</udiDi>
    <basicUdiDi>B-08806369412582</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161318</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:39:23.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412568</udiDi>
    <basicUdiDi>B-08806369412568</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161218</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:39:20.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412544</udiDi>
    <basicUdiDi>B-08806369412544</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161118</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:39:17.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412520</udiDi>
    <basicUdiDi>B-08806369412520</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-161018</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:39:14.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412506</udiDi>
    <basicUdiDi>B-08806369412506</basicUdiDi>
    <tradeName>BONASTENT® Duodenal/Pyloric Covered</tradeName>
    <deviceName>Sterile Single-use Duodenal/Pyloric Stent</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPC-160918</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:38:59.907Z</lastUpdated>
  </row>
</eudamedExport>