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<eudamedExport entity="devices">
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    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524316</tradeName>
    <deviceName>Dilation Balloon Catheter</deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:57:40.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024695</udiDi>
    <basicUdiDi>B-04044503024695</basicUdiDi>
    <tradeName>DIL1-A1-20-60-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:37:00.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024589</udiDi>
    <basicUdiDi>B-04044503024589</basicUdiDi>
    <tradeName>DIL1-A1-18-60-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146667</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:53.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024572</udiDi>
    <basicUdiDi>B-04044503024572</basicUdiDi>
    <tradeName>DIL1-A1-16-60-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146670</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:53.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024565</udiDi>
    <basicUdiDi>B-04044503024565</basicUdiDi>
    <tradeName>DIL1-A1-14-60-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146664</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:52.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024558</udiDi>
    <basicUdiDi>B-04044503024558</basicUdiDi>
    <tradeName>DIL1-A1-12-60-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:51.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024541</udiDi>
    <basicUdiDi>B-04044503024541</basicUdiDi>
    <tradeName>DIL1-A1-10-40-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146663</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:47.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024534</udiDi>
    <basicUdiDi>B-04044503024534</basicUdiDi>
    <tradeName>DIL1-A1-06-40-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146636</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:46.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044503024527</udiDi>
    <basicUdiDi>B-04044503024527</basicUdiDi>
    <tradeName>DIL1-A1-08-40-23-35</tradeName>
    <deviceName>DIL1-A1-Series</deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146669</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:36:45.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492226</udiDi>
    <basicUdiDi>B-00827002492226</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-10X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:22.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492219</udiDi>
    <basicUdiDi>B-00827002492219</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-8X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:21.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492202</udiDi>
    <basicUdiDi>B-00827002492202</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-6X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:20.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492196</udiDi>
    <basicUdiDi>B-00827002492196</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-4X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:20.064Z</lastUpdated>
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  <row>
    <udiDi>06902284524323</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524323</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902284524330</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524330</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902284524347</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524347</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.656Z</lastUpdated>
  </row>
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    <udiDi>06902284524354</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524354</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902284524361</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524361</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902284524378</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524378</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902284524385</udiDi>
    <basicUdiDi>6902284EC457129U</basicUdiDi>
    <tradeName>06902284524385</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micro-Tech (Nanjing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006950</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC01007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:13:03.605Z</lastUpdated>
  </row>
</eudamedExport>