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    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10120818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:14.757Z</lastUpdated>
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    <udiDi>08809243910051</udiDi>
    <basicUdiDi>B-08809243910051</basicUdiDi>
    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10100818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:13.953Z</lastUpdated>
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    <udiDi>08809243910044</udiDi>
    <basicUdiDi>B-08809243910044</basicUdiDi>
    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10090818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:09.953Z</lastUpdated>
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    <udiDi>08809243910037</udiDi>
    <basicUdiDi>B-08809243910037</basicUdiDi>
    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10080818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:09.161Z</lastUpdated>
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    <udiDi>08809243910020</udiDi>
    <basicUdiDi>B-08809243910020</basicUdiDi>
    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10070818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:08.354Z</lastUpdated>
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    <udiDi>08809243910013</udiDi>
    <basicUdiDi>B-08809243910013</basicUdiDi>
    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10060818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:07.551Z</lastUpdated>
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    <udiDi>08809243910006</udiDi>
    <basicUdiDi>B-08809243910006</basicUdiDi>
    <tradeName>EGIS Flower Biliary Partial Covered Stent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VASNOVA INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000015781</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0502</emdnCode>
    <emdnDescription>BILIARY AND PANCREATIC PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFPB10050818</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:02.750Z</lastUpdated>
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    <udiDi>08809234339502</udiDi>
    <basicUdiDi>B-08809234339502</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Kaffes]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Kaffes]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1006F2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:21.232Z</lastUpdated>
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  <row>
    <udiDi>08809234339496</udiDi>
    <basicUdiDi>B-08809234339496</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Kaffes]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Kaffes]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS0804F2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:20.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809234339298</udiDi>
    <basicUdiDi>B-08809234339298</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1010FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:49.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809234339281</udiDi>
    <basicUdiDi>B-08809234339281</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1009FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:48.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809234339274</udiDi>
    <basicUdiDi>B-08809234339274</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1008FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:47.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809234339267</udiDi>
    <basicUdiDi>B-08809234339267</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1007FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:18.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809234339250</udiDi>
    <basicUdiDi>B-08809234339250</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1006FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:16.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809234339243</udiDi>
    <basicUdiDi>B-08809234339243</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1005FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:16.169Z</lastUpdated>
  </row>
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    <udiDi>08809234339236</udiDi>
    <basicUdiDi>B-08809234339236</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Flare-Type]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Flare-Type]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>TS1004FW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:15.367Z</lastUpdated>
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    <udiDi>08809234338987</udiDi>
    <basicUdiDi>B-08809234338987</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>BK0608CW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:11.369Z</lastUpdated>
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    <udiDi>08809234338970</udiDi>
    <basicUdiDi>B-08809234338970</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>BK0606CW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:10.617Z</lastUpdated>
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    <udiDi>08809234338963</udiDi>
    <basicUdiDi>B-08809234338963</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>BK0605CW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:09.772Z</lastUpdated>
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    <udiDi>08809234338956</udiDi>
    <basicUdiDi>B-08809234338956</basicUdiDi>
    <tradeName>Niti-S Biliary Covered Stent [Bumpy]</tradeName>
    <deviceName>Niti-S Biliary Covered Stent [Bumpy]</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</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>BK0604CW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:41:08.967Z</lastUpdated>
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