<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800089800131</udiDi>
    <basicUdiDi>88000898001313V</basicUdiDi>
    <tradeName>9 Pin Screw Multi Needle</tradeName>
    <deviceName>Multi Needle</deviceName>
    <manufacturerName>Huons Meditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016623</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019006</emdnCode>
    <emdnDescription>MESOTHERAPY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-NDL9P34G1</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:15.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800071200130</udiDi>
    <basicUdiDi>8800071200130UF</basicUdiDi>
    <tradeName>ENDOCEM PREMIXED REGULAR(3 g)</tradeName>
    <deviceName>ENDOCEM MTA PREMIXED REGULAR</deviceName>
    <manufacturerName>MARUCHI</manufacturerName>
    <manufacturerSrn>KR-MF-000030192</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00130</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:43.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800071200123</udiDi>
    <basicUdiDi>8800071200123UJ</basicUdiDi>
    <tradeName>ENDOCEM MTA PREMIXED LIGHT(3 g)</tradeName>
    <deviceName>ENDOCEM MTA PREMIXED LIGHT</deviceName>
    <manufacturerName>MARUCHI</manufacturerName>
    <manufacturerSrn>KR-MF-000030192</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00123</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:39.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800071200093</udiDi>
    <basicUdiDi>8800071200093V2</basicUdiDi>
    <tradeName>White ENDOSEAL MTA(3 g)</tradeName>
    <deviceName>White ENDOSEAL MTA</deviceName>
    <manufacturerName>MARUCHI</manufacturerName>
    <manufacturerSrn>KR-MF-000030192</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00093</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:39.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800071200017</udiDi>
    <basicUdiDi>8800071200017UJ</basicUdiDi>
    <tradeName>08800071200017</tradeName>
    <deviceName>CleaniCal</deviceName>
    <manufacturerName>MARUCHI</manufacturerName>
    <manufacturerSrn>KR-MF-000030192</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00017</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:37.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800071200000</udiDi>
    <basicUdiDi>8800071200000TZ</basicUdiDi>
    <tradeName>ENDOSEAL MTA(3 g)</tradeName>
    <deviceName>ENDOSEAL MTA</deviceName>
    <manufacturerName>MARUCHI</manufacturerName>
    <manufacturerSrn>KR-MF-000030192</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00000</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:36.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800063401484</udiDi>
    <basicUdiDi>880006340NRP1BU</basicUdiDi>
    <tradeName>Positioning  Pad</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cworld</manufacturerName>
    <manufacturerSrn>KR-MF-000047459</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V080302</emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-RP-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:03.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800063400357</udiDi>
    <basicUdiDi>8800063400296WT</basicUdiDi>
    <tradeName>Tru-Comfi Curtain Shield</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cworld</manufacturerName>
    <manufacturerSrn>KR-MF-000047459</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030499</emdnCode>
    <emdnDescription>RADIOTHERAPY PROTECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-XR-g-5-L</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:03.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800063400326</udiDi>
    <basicUdiDi>8800063400302VV</basicUdiDi>
    <tradeName>TRU-COMFI (Lead)</tradeName>
    <deviceName>Front Shield Apron</deviceName>
    <manufacturerName>Cworld</manufacturerName>
    <manufacturerSrn>KR-MF-000047459</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030499</emdnCode>
    <emdnDescription>RADIOTHERAPY PROTECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-XR-1-L</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:46.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053099301</udiDi>
    <basicUdiDi>88000530LM400B7</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:19.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053095952</udiDi>
    <basicUdiDi>88000530M300DT</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:17.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053094351</udiDi>
    <basicUdiDi>88000530LM200AV</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:15.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093767</udiDi>
    <basicUdiDi>88000530S300F5</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:14.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093644</udiDi>
    <basicUdiDi>88000530S250FF</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSM-V4-202510-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:13.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093460</udiDi>
    <basicUdiDi>88000530S200EY</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:10.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053091305</udiDi>
    <basicUdiDi>88000530DC1RZ</basicUdiDi>
    <tradeName>Luvis Chair</tradeName>
    <deviceName>Luvis Chair</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110101</emdnCode>
    <emdnDescription>DENTAL TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC700C-chair only</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:09.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053091237</udiDi>
    <basicUdiDi>88000530STBD</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Operating Table</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVST-V3-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:08.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053084123</udiDi>
    <basicUdiDi>88000530DISAKB</basicUdiDi>
    <tradeName>ChecQ</tradeName>
    <deviceName>ChecQ</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:06.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053082655</udiDi>
    <basicUdiDi>88000530AISU6</basicUdiDi>
    <tradeName>DENOPS-i</tradeName>
    <deviceName>DENOPS-i</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020203</emdnCode>
    <emdnDescription>CARTRIDGE SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:02.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053045049</udiDi>
    <basicUdiDi>88000530C600C4</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Dental Light</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:02.221Z</lastUpdated>
  </row>
</eudamedExport>