<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800026616092</udiDi>
    <basicUdiDi>B-08800026616092</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1012HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:44.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616085</udiDi>
    <basicUdiDi>B-08800026616085</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1011HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:43.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616078</udiDi>
    <basicUdiDi>B-08800026616078</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1010HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:40.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616061</udiDi>
    <basicUdiDi>B-08800026616061</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1009HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:39.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616054</udiDi>
    <basicUdiDi>B-08800026616054</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1008HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:38.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616047</udiDi>
    <basicUdiDi>B-08800026616047</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1007HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:36.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616030</udiDi>
    <basicUdiDi>B-08800026616030</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1006HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:34.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616023</udiDi>
    <basicUdiDi>B-08800026616023</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1005HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:31.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616016</udiDi>
    <basicUdiDi>B-08800026616016</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN1004HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:31.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026616009</udiDi>
    <basicUdiDi>B-08800026616009</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0912HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:29.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615996</udiDi>
    <basicUdiDi>B-08800026615996</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0911HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:27.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615989</udiDi>
    <basicUdiDi>B-08800026615989</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0910HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:25.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615972</udiDi>
    <basicUdiDi>B-08800026615972</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0909HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:24.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615965</udiDi>
    <basicUdiDi>B-08800026615965</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0908HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:23.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615934</udiDi>
    <basicUdiDi>B-08800026615934</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0905HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:20.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615958</udiDi>
    <basicUdiDi>B-08800026615958</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0907HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:18.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615941</udiDi>
    <basicUdiDi>B-08800026615941</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0906HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:17.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615927</udiDi>
    <basicUdiDi>B-08800026615927</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0904HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:36:00.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615910</udiDi>
    <basicUdiDi>B-08800026615910</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0812HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:35:59.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026615903</udiDi>
    <basicUdiDi>B-08800026615903</basicUdiDi>
    <tradeName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</tradeName>
    <deviceName>"HILZO Biliary Covered Stent (PTFE) with Nylon Suture "</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>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVN0811HC1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-04T08:35:58.977Z</lastUpdated>
  </row>
</eudamedExport>