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<eudamedExport entity="devices">
  <row>
    <udiDi>08800048017501</udiDi>
    <basicUdiDi>88000480TLDOCMDR600NZ</basicUdiDi>
    <tradeName>RenoSiGel</tradeName>
    <deviceName>Silicone Gel Sheet</deviceName>
    <manufacturerName>T&amp;L Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016624</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040701</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI14EN02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:18.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800048017495</udiDi>
    <basicUdiDi>88000480TLDOCMDR410NS</basicUdiDi>
    <tradeName>Mighty Shield</tradeName>
    <deviceName>Skin Protective Bandage</deviceName>
    <manufacturerName>T&amp;L Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016624</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030202</emdnCode>
    <emdnDescription>SKIN PROTECTIVE BANDAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:14.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800048015965</udiDi>
    <basicUdiDi>88000480TLDOCMDR150NP</basicUdiDi>
    <tradeName>Mighty patch</tradeName>
    <deviceName>Hydrocolloid Dressing</deviceName>
    <manufacturerName>T&amp;L Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016624</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040301</emdnCode>
    <emdnDescription>HYDROCOLLOID DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPB001EU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:13.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800044300034</udiDi>
    <basicUdiDi>88000443dRASTT8</basicUdiDi>
    <tradeName>dRAST</tradeName>
    <deviceName>dRAST</deviceName>
    <manufacturerName>QuantaMatrix Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022784</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QMdRASTR02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:34.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035304669</udiDi>
    <basicUdiDi>88000353ChemiSiLBiteJU</basicUdiDi>
    <tradeName>Chemi-SiL Bite-Blu</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;E KOREA Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000030252</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#513100</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:11.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035300562</udiDi>
    <basicUdiDi>88000353ChemiSiLLBRY</basicUdiDi>
    <tradeName>Chemi-SiL LB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;E KOREA Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000030252</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#512100</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:07.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800035300814</udiDi>
    <basicUdiDi>88000353ChemiSiLHBRL</basicUdiDi>
    <tradeName>Chemi-SiL HB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;E KOREA Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000030252</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#511100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:05.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902533</udiDi>
    <basicUdiDi>88000299GTUTL20WB</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-4000 / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:48.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902502</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902502</tradeName>
    <deviceName>ENT Endoscopy Visual System</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT Endoscopy Visual System / MGSI-CA-260SLCB</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:47.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902496</udiDi>
    <basicUdiDi>88000299GTCA10GQ</basicUdiDi>
    <tradeName>ENT Chair</tradeName>
    <deviceName>ENT Chair</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-1500D / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:45.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902489</udiDi>
    <basicUdiDi>88000299GTUTM20WG</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-600A / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:44.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902472</udiDi>
    <basicUdiDi>88000299GTUT20PQ</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-1100 / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:43.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029901826</udiDi>
    <basicUdiDi>88000299SNSS11RW</basicUdiDi>
    <tradeName>NAVILLOON-E</tradeName>
    <deviceName>Sterile Single-use Balloon Catheter for Eustachian tube Dilatation</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030308</emdnCode>
    <emdnDescription>ENT SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navilloon-e / Catalog ver. 2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:42.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026800200</udiDi>
    <basicUdiDi>88000268AD9K</basicUdiDi>
    <tradeName>Oral wound dressing</tradeName>
    <deviceName>Oral wound dressing</deviceName>
    <manufacturerName>TBM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008542</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:13.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026800149</udiDi>
    <basicUdiDi>88000268AG9R</basicUdiDi>
    <tradeName>Ora-Aid</tradeName>
    <deviceName>Ora-Aid</deviceName>
    <manufacturerName>TBM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008542</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010304</emdnCode>
    <emdnDescription>PERIODONTAL DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF-ORA-IFU</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:12.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800005200328</udiDi>
    <basicUdiDi>88000052009LX</basicUdiDi>
    <tradeName>WillCeph</tradeName>
    <deviceName>WillCeph</deviceName>
    <manufacturerName>HDX WILL Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000019877</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030392</emdnCode>
    <emdnDescription>INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WillCeph</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:41.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800005200311</udiDi>
    <basicUdiDi>88000052008LV</basicUdiDi>
    <tradeName>WillCeph Pro</tradeName>
    <deviceName>WillCeph Pro</deviceName>
    <manufacturerName>HDX WILL Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000019877</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WillCeph Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:37.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800005200298</udiDi>
    <basicUdiDi>88000052004LM</basicUdiDi>
    <tradeName>Will3D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HDX WILL Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000019877</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030392</emdnCode>
    <emdnDescription>INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNW312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:36.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809518340651</udiDi>
    <basicUdiDi>B-08809518340651</basicUdiDi>
    <tradeName>Once-Fil Flow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDICLUS Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022584</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GB2021OC006(092021)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:14:47.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809518341160</udiDi>
    <basicUdiDi>B-08809518341160</basicUdiDi>
    <tradeName>Any-Seal RC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDICLUS Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022584</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GB2021OC005(012022)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:14:47.833Z</lastUpdated>
  </row>
</eudamedExport>