<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800026657279</udiDi>
    <basicUdiDi>B-08800026657279</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2021HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468541344</udiDi>
    <basicUdiDi>B-08809468541344</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>EVP2312HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423567747</udiDi>
    <basicUdiDi>B-08809423567747</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE) with Nylon Suture</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>EVP2212HC2-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657286</udiDi>
    <basicUdiDi>B-08800026657286</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2022HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657293</udiDi>
    <basicUdiDi>B-08800026657293</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2023HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423567754</udiDi>
    <basicUdiDi>B-08809423567754</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE) with Nylon Suture</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>EVP2213HC2-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468541351</udiDi>
    <basicUdiDi>B-08809468541351</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>EVP2313HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657309</udiDi>
    <basicUdiDi>B-08800026657309</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2216HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423567761</udiDi>
    <basicUdiDi>B-08809423567761</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE) with Nylon Suture</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-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468541368</udiDi>
    <basicUdiDi>B-08809468541368</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>EVP2314HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657316</udiDi>
    <basicUdiDi>B-08800026657316</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2217HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468541375</udiDi>
    <basicUdiDi>B-08809468541375</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>EVP2315HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423567778</udiDi>
    <basicUdiDi>B-08809423567778</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE) with Nylon Suture</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-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657323</udiDi>
    <basicUdiDi>B-08800026657323</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2218HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468541382</udiDi>
    <basicUdiDi>B-08809468541382</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>EVP2406HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423567785</udiDi>
    <basicUdiDi>B-08809423567785</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE) with Nylon Suture</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-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657330</udiDi>
    <basicUdiDi>B-08800026657330</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2219HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423567792</udiDi>
    <basicUdiDi>B-08809423567792</basicUdiDi>
    <tradeName>HILZO Esophageal Covered Stent (PTFE) with Nylon Suture</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-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809468541399</udiDi>
    <basicUdiDi>B-08809468541399</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>EVP2407HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026657347</udiDi>
    <basicUdiDi>B-08800026657347</basicUdiDi>
    <tradeName>HILZO Esophageal 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>P050101</emdnCode>
    <emdnDescription>GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVP2220HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:53.181Z</lastUpdated>
  </row>
</eudamedExport>