<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800026600480</udiDi>
    <basicUdiDi>B-08800026600480</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP1914HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600497</udiDi>
    <basicUdiDi>B-08800026600497</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP1915HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600503</udiDi>
    <basicUdiDi>B-08800026600503</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2006HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600510</udiDi>
    <basicUdiDi>B-08800026600510</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2007HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600527</udiDi>
    <basicUdiDi>B-08800026600527</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2008HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600534</udiDi>
    <basicUdiDi>B-08800026600534</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2009HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633082</udiDi>
    <basicUdiDi>B-08800026633082</basicUdiDi>
    <tradeName>HILZO Ureteral Stent System</tradeName>
    <deviceName>HILZO Ureteral 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>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0704</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600541</udiDi>
    <basicUdiDi>B-08800026600541</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2010HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633563</udiDi>
    <basicUdiDi>B-08800026633563</basicUdiDi>
    <tradeName>HILZO Ureteral Stent System</tradeName>
    <deviceName>HILZO Ureteral 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>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0704-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600558</udiDi>
    <basicUdiDi>B-08800026600558</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2011HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633099</udiDi>
    <basicUdiDi>B-08800026633099</basicUdiDi>
    <tradeName>HILZO Ureteral Stent System</tradeName>
    <deviceName>HILZO Ureteral 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>P08030102</emdnCode>
    <emdnDescription>VAS DEFERENS PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0705</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600565</udiDi>
    <basicUdiDi>B-08800026600565</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2012HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633570</udiDi>
    <basicUdiDi>B-08800026633570</basicUdiDi>
    <tradeName>HILZO Ureteral Stent System</tradeName>
    <deviceName>HILZO Ureteral 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>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0705-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600572</udiDi>
    <basicUdiDi>B-08800026600572</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2013HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633105</udiDi>
    <basicUdiDi>B-08800026633105</basicUdiDi>
    <tradeName>HILZO Ureteral 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>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0706</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600589</udiDi>
    <basicUdiDi>B-08800026600589</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2014HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633587</udiDi>
    <basicUdiDi>B-08800026633587</basicUdiDi>
    <tradeName>HILZO Ureteral Stent System</tradeName>
    <deviceName>HILZO Ureteral 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>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0706-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026600596</udiDi>
    <basicUdiDi>B-08800026600596</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP2015HUW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026633594</udiDi>
    <basicUdiDi>B-08800026633594</basicUdiDi>
    <tradeName>HILZO Ureteral Stent System</tradeName>
    <deviceName>HILZO Ureteral 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>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UVN0707-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026613039</udiDi>
    <basicUdiDi>B-08800026613039</basicUdiDi>
    <tradeName>HILZO Pyloric/Duodenal 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>MDD</legislation>
    <emdnCode>P0503</emdnCode>
    <emdnDescription>COLONIC AND DUODENAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVP1810TC1-3U</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:52:56.358Z</lastUpdated>
  </row>
</eudamedExport>