<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>08809709380237</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Foot Switch</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>TMFS01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380244</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA Cooling Gas</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>TMCG01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380329</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>TMBT20.0-1000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380336</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>TMET0.25-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709380374</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA</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>10THERMA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809709381142</udiDi>
    <basicUdiDi>880970938TMSY03ZR</basicUdiDi>
    <tradeName>10THERMA-BK</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>10THERMA-BK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:49.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910163</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910163</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910170</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910170</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910187</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910187</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910194</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910194</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910255</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910255</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910262</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910262</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910279</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910279</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910286</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910286</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809766910293</udiDi>
    <basicUdiDi>88097669VSPB119S</basicUdiDi>
    <tradeName>08809766910293</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VALUE &amp; TRUST Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026538</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060309</emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL SPINE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-4600-9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:25.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809910782080</udiDi>
    <basicUdiDi>B-08809910782080</basicUdiDi>
    <tradeName>DUAL PATTY V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENDOVISION Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026324</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPV0060006B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:26.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809910782356</udiDi>
    <basicUdiDi>B-08809910782356</basicUdiDi>
    <tradeName>DUAL PATTY V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENDOVISION Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026324</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPV012575B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:26.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809910782363</udiDi>
    <basicUdiDi>B-08809910782363</basicUdiDi>
    <tradeName>DUAL PATTY V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ENDOVISION Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026324</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPV012575B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:26.030Z</lastUpdated>
  </row>
</eudamedExport>