<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800026601883</udiDi>
    <basicUdiDi>B-08800026601883</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV2414W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601890</udiDi>
    <basicUdiDi>B-08800026601890</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2415W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601364</udiDi>
    <basicUdiDi>B-08800026601364</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1912W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602279</udiDi>
    <basicUdiDi>B-08800026602279</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1913HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601371</udiDi>
    <basicUdiDi>B-08800026601371</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1913W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602286</udiDi>
    <basicUdiDi>B-08800026602286</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1914HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601388</udiDi>
    <basicUdiDi>B-08800026601388</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1914W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602293</udiDi>
    <basicUdiDi>B-08800026602293</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1915HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601395</udiDi>
    <basicUdiDi>B-08800026601395</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV1915W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:35.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602309</udiDi>
    <basicUdiDi>B-08800026602309</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2006HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601401</udiDi>
    <basicUdiDi>B-08800026601401</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2006W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602316</udiDi>
    <basicUdiDi>B-08800026602316</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2007HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601418</udiDi>
    <basicUdiDi>B-08800026601418</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2007W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602323</udiDi>
    <basicUdiDi>B-08800026602323</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2008HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601425</udiDi>
    <basicUdiDi>B-08800026601425</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2008W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602330</udiDi>
    <basicUdiDi>B-08800026602330</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2009HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601432</udiDi>
    <basicUdiDi>B-08800026601432</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2009W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602347</udiDi>
    <basicUdiDi>B-08800026602347</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2010HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026601449</udiDi>
    <basicUdiDi>B-08800026601449</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2010W</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026602354</udiDi>
    <basicUdiDi>B-08800026602354</basicUdiDi>
    <tradeName>HILZO Colonic Uncovered Stent System</tradeName>
    <deviceName>HILZO Colonic Uncovered Stent System</deviceName>
    <manufacturerName>BCM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017292</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>CV2011HW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:53:34.682Z</lastUpdated>
  </row>
</eudamedExport>