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<eudamedExport entity="devices">
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    <udiDi>08806369412483</udiDi>
    <basicUdiDi>B-08806369412483</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-160818</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:38:54.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412469</udiDi>
    <basicUdiDi>B-08806369412469</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-160718</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:38:48.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412445</udiDi>
    <basicUdiDi>B-08806369412445</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-160618</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:38:42.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412421</udiDi>
    <basicUdiDi>B-08806369412421</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-161812</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:38:02.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412407</udiDi>
    <basicUdiDi>B-08806369412407</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-161712</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:58.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412384</udiDi>
    <basicUdiDi>B-08806369412384</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-161612</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:55.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412360</udiDi>
    <basicUdiDi>B-08806369412360</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-161512</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:52.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412346</udiDi>
    <basicUdiDi>B-08806369412346</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-161412</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:37.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412322</udiDi>
    <basicUdiDi>B-08806369412322</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-161312</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:33.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412308</udiDi>
    <basicUdiDi>B-08806369412308</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-161212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:30.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412261</udiDi>
    <basicUdiDi>B-08806369412261</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-161012</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:27.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412247</udiDi>
    <basicUdiDi>B-08806369412247</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-160912</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:11.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412223</udiDi>
    <basicUdiDi>B-08806369412223</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-160812</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:07.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412209</udiDi>
    <basicUdiDi>B-08806369412209</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-160712</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:04.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369412186</udiDi>
    <basicUdiDi>B-08806369412186</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-160612</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:37:01.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369403801</udiDi>
    <basicUdiDi>B-08806369403801</basicUdiDi>
    <tradeName>08806369403801</tradeName>
    <deviceName>Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105-018</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:36:41.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369403788</udiDi>
    <basicUdiDi>B-08806369403788</basicUdiDi>
    <tradeName>08806369403788</tradeName>
    <deviceName>Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105-016</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:36:38.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369403764</udiDi>
    <basicUdiDi>B-08806369403764</basicUdiDi>
    <tradeName>08806369403764</tradeName>
    <deviceName>Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105-014</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:36:35.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369403740</udiDi>
    <basicUdiDi>B-08806369403740</basicUdiDi>
    <tradeName>08806369403740</tradeName>
    <deviceName>Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105-012</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:36:32.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806369403726</udiDi>
    <basicUdiDi>B-08806369403726</basicUdiDi>
    <tradeName>08806369403726</tradeName>
    <deviceName>Sterile Single-use All-Silicone Foley Balloon Catheter (Temperature Sensing)</deviceName>
    <manufacturerName>SEWOONMEDICAL CO.,LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000019142</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105-010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-10-05T10:36:15.053Z</lastUpdated>
  </row>
</eudamedExport>