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<eudamedExport entity="devices">
  <row>
    <udiDi>08806367093158</udiDi>
    <basicUdiDi>B-08806367093158</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Pancreatic drainage stent with Electrocautery Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCF-12-020-T140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:59:43.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367093141</udiDi>
    <basicUdiDi>B-08806367093141</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Pancreatic drainage stent with Electrocautery Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCF-10-040-T140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:59:42.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367093134</udiDi>
    <basicUdiDi>B-08806367093134</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Pancreatic drainage stent with Electrocautery Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCF-10-030-T140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:59:41.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806367093127</udiDi>
    <basicUdiDi>B-08806367093127</basicUdiDi>
    <tradeName>HANAROSTENT®</tradeName>
    <deviceName>Pancreatic drainage stent with Electrocautery Delivery System</deviceName>
    <manufacturerName>M.I.Tech Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCF-10-020-T140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:59:37.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100353</udiDi>
    <basicUdiDi>B-08800042100353</basicUdiDi>
    <tradeName>ANT-36</tradeName>
    <deviceName>Sterile Disposable Electrode</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0911</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:47.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100346</udiDi>
    <basicUdiDi>B-08800042100346</basicUdiDi>
    <tradeName>ANN-36</tradeName>
    <deviceName>Sterile Disposable Electrode</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0911</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:43.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800042100339</udiDi>
    <basicUdiDi>B-08800042100339</basicUdiDi>
    <tradeName>ANI-36</tradeName>
    <deviceName>Sterile Disposable Electrode</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0911</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:42.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301301104</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301301104</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301301111</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301301111</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-6</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301301128</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301301128</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-NC70</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301301135</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301301135</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-NT55</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303467</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303467</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-BC160</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303474</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303474</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-BC70</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303498</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303498</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-OS80</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303504</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303504</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-NS70</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303511</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303511</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-NS150</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303528</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303528</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-BS70</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303535</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303535</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-BS160</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303542</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303542</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-OC80</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944301303566</udiDi>
    <basicUdiDi>69443013010002N2</basicUdiDi>
    <tradeName>06944301303566</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Jinhua Huatong Medical Appliance Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010166</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-DT-NC150</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:08:06.437Z</lastUpdated>
  </row>
</eudamedExport>