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<eudamedExport entity="devices">
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    <udiDi>08800020107473</udiDi>
    <basicUdiDi>B-08800020107473</basicUdiDi>
    <tradeName>S-49 Electrode</tradeName>
    <deviceName>S-49 TIP</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-49</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:54.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800020100481</udiDi>
    <basicUdiDi>B-08800020100481</basicUdiDi>
    <tradeName>CP-21 TIP</tradeName>
    <deviceName>CP-21 TIP</deviceName>
    <manufacturerName>Jeisys Medical Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000008513</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-21</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:48.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424210165</udiDi>
    <basicUdiDi>B-06975424210165</basicUdiDi>
    <tradeName>V-Cure Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</tradeName>
    <deviceName>Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</deviceName>
    <manufacturerName>Resonant Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032264</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975424210165</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:33.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424210172</udiDi>
    <basicUdiDi>B-06975424210172</basicUdiDi>
    <tradeName>V-Cure Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</tradeName>
    <deviceName>Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</deviceName>
    <manufacturerName>Resonant Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032264</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975424210172</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:32.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424210141</udiDi>
    <basicUdiDi>B-06975424210141</basicUdiDi>
    <tradeName>V-Cure Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</tradeName>
    <deviceName>Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</deviceName>
    <manufacturerName>Resonant Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032264</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975424210141</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:31.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424210158</udiDi>
    <basicUdiDi>B-06975424210158</basicUdiDi>
    <tradeName>V-Cure Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</tradeName>
    <deviceName>Sterile Peripheral Vascular Radiofrequency Electrosurgical Ablation Catheters</deviceName>
    <manufacturerName>Resonant Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032264</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975424210158</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:29.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380091</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName>Electrosurgical Unit</deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMET0.25-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:46.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809495930364</udiDi>
    <basicUdiDi>880949593930QF</basicUdiDi>
    <tradeName>ELLISYS PLUS</tradeName>
    <deviceName>Fractional RF Surgical Unit with Sterile MicroNeedle</deviceName>
    <manufacturerName>Chungwoo Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017583</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CWM-930M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:32.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809495930753</udiDi>
    <basicUdiDi>880949593930QF</basicUdiDi>
    <tradeName>ELLISYS SENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chungwoo Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017583</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CWM-930S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:14:48.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054247254391</udiDi>
    <basicUdiDi>805424725EXTENSIONUB</basicUdiDi>
    <tradeName>Cavi di connessione</tradeName>
    <deviceName>CAVI DI CONNESSIONE</deviceName>
    <manufacturerName>ADVANCED MEDICAL SYSTEMS GROUP S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000036848</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMS-200-BA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:04:06.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380107</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMFT4.0-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:12:03.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380114</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMFT4.0-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380121</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMFT4.0-900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380138</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMFT5.0-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380145</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMFT5.0-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380169</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMFT5.0-900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380176</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMBT20.0-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380183</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Coupling Fluid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMCF01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380190</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Return Pad</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMRP01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380220</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TENTECH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035109</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K020380</emdnCode>
    <emdnDescription>DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMHP01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.271Z</lastUpdated>
  </row>
</eudamedExport>