<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800026656944</udiDi>
    <basicUdiDi>B-08800026656944</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>EVP2420HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569239</udiDi>
    <basicUdiDi>B-08809423569239</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>EVP2411HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026656951</udiDi>
    <basicUdiDi>B-08800026656951</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>EVP2421HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569246</udiDi>
    <basicUdiDi>B-08809423569246</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>EVP2412HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026656968</udiDi>
    <basicUdiDi>B-08800026656968</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>EVP2422HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569253</udiDi>
    <basicUdiDi>B-08809423569253</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>EVP2413HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026656975</udiDi>
    <basicUdiDi>B-08800026656975</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>EVP2423HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569260</udiDi>
    <basicUdiDi>B-08809423569260</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>EVP2414HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569277</udiDi>
    <basicUdiDi>B-08809423569277</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>EVP2415HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026643319</udiDi>
    <basicUdiDi>B-08800026643319</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>EVP1806HU1-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569284</udiDi>
    <basicUdiDi>B-08809423569284</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>EVP2506HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026643326</udiDi>
    <basicUdiDi>B-08800026643326</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>EVP1807HU1-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026643333</udiDi>
    <basicUdiDi>B-08800026643333</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>EVP1808HU1-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569291</udiDi>
    <basicUdiDi>B-08809423569291</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>EVP2507HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569307</udiDi>
    <basicUdiDi>B-08809423569307</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>EVP2508HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026643340</udiDi>
    <basicUdiDi>B-08800026643340</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>EVP1809HU1-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569314</udiDi>
    <basicUdiDi>B-08809423569314</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>EVP2509HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026643357</udiDi>
    <basicUdiDi>B-08800026643357</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>EVP1810HU1-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:37.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809423569321</udiDi>
    <basicUdiDi>B-08809423569321</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>EVP2510HU1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:36.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026643364</udiDi>
    <basicUdiDi>B-08800026643364</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>EVP1811HU1-I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-10T03:46:36.944Z</lastUpdated>
  </row>
</eudamedExport>