<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809468542365</udiDi>
    <basicUdiDi>B-08809468542365</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2214HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542709</udiDi>
    <basicUdiDi>B-08809468542709</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2608HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542372</udiDi>
    <basicUdiDi>B-08809468542372</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2215HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423568690</udiDi>
    <basicUdiDi>B-08809423568690</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE/Partially Covered)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP1907HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542716</udiDi>
    <basicUdiDi>B-08809468542716</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2609HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542389</udiDi>
    <basicUdiDi>B-08809468542389</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2306HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423568706</udiDi>
    <basicUdiDi>B-08809423568706</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE/Partially Covered)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP1908HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542396</udiDi>
    <basicUdiDi>B-08809468542396</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2307HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423568713</udiDi>
    <basicUdiDi>B-08809423568713</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE/Partially Covered)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP1909HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542723</udiDi>
    <basicUdiDi>B-08809468542723</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2610HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423568720</udiDi>
    <basicUdiDi>B-08809423568720</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE/Partially Covered)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP1910HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542730</udiDi>
    <basicUdiDi>B-08809468542730</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2611HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542402</udiDi>
    <basicUdiDi>B-08809468542402</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2308HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423568737</udiDi>
    <basicUdiDi>B-08809423568737</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE/Partially Covered)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP1911HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542419</udiDi>
    <basicUdiDi>B-08809468542419</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2309HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542747</udiDi>
    <basicUdiDi>B-08809468542747</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2612HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542754</udiDi>
    <basicUdiDi>B-08809468542754</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2613HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542426</udiDi>
    <basicUdiDi>B-08809468542426</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2310HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423568744</udiDi>
    <basicUdiDi>B-08809423568744</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE/Partially Covered)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP1912HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468542433</udiDi>
    <basicUdiDi>B-08809468542433</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE)</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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2311HC2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:43.058Z</lastUpdated>
  </row>
</eudamedExport>