<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>18800076500515</udiDi>
    <basicUdiDi>88000765UC02N2</basicUdiDi>
    <tradeName>Urine Collection Tube Ⅱ</tradeName>
    <deviceName>Urine Collection Tube Ⅱ</deviceName>
    <manufacturerName>Genomictree, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037890</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010202</emdnCode>
    <emdnDescription>URINE COLLECTION, TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC02-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:31:16.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800076500461</udiDi>
    <basicUdiDi>88000765PREP1PX</basicUdiDi>
    <tradeName>GT NUCLEIC ACID PREP KIT</tradeName>
    <deviceName>GT NUCLEIC ACID PREP KIT</deviceName>
    <manufacturerName>Genomictree, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037890</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT-PREP-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:31:16.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800076500447</udiDi>
    <basicUdiDi>88000765SC03MN</basicUdiDi>
    <tradeName>Stool Collection Kit Ⅲ</tradeName>
    <deviceName>Stool Collection Kit Ⅲ</deviceName>
    <manufacturerName>Genomictree, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037890</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC03-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:31:15.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800313232035</udiDi>
    <basicUdiDi>88000530LC9N</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110101</emdnCode>
    <emdnDescription>DENTAL TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC700C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:48.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800266945068</udiDi>
    <basicUdiDi>88000530E100BR</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Luminaire for diagnosis</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>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:47.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800266944375</udiDi>
    <basicUdiDi>88000530C500BX</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>2026-07-03T17:30:46.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800251000000</udiDi>
    <basicUdiDi>88000571TD701F2</basicUdiDi>
    <tradeName>08800251000000</tradeName>
    <deviceName>Zirtooth</deviceName>
    <manufacturerName>HASS CORP.</manufacturerName>
    <manufacturerSrn>KR-MF-000011621</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Zirtooth H S-4019-H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:44.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800101600015</udiDi>
    <basicUdiDi>880010160RHSWAN</basicUdiDi>
    <tradeName>rebless</tradeName>
    <deviceName>rebless</deviceName>
    <manufacturerName>H ROBOTICS INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000011627</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12069099</emdnCode>
    <emdnDescription>VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2018</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:48.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099090966</udiDi>
    <basicUdiDi>88000990BDEWN</basicUdiDi>
    <tradeName>Blade</tradeName>
    <deviceName>Blade</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDB12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:41.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099090829</udiDi>
    <basicUdiDi>88000990RDBYY</basicUdiDi>
    <tradeName>Ratchet Detachable Blade</tradeName>
    <deviceName>Ratchet Detachable Blade</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDB-MSE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:40.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099090805</udiDi>
    <basicUdiDi>88000990EGBX8</basicUdiDi>
    <tradeName>Engine Blade</tradeName>
    <deviceName>Engine Blade</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEB12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:40.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099071958</udiDi>
    <basicUdiDi>88000990DRBY4</basicUdiDi>
    <tradeName>08800099071958</tradeName>
    <deviceName>Driver Blade</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDB-15C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:35.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099071880</udiDi>
    <basicUdiDi>88000990SEBZ8</basicUdiDi>
    <tradeName>08800099071880</tradeName>
    <deviceName>Short Engine Blade</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEB-SL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:34.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099071873</udiDi>
    <basicUdiDi>88000990LEBY5</basicUdiDi>
    <tradeName>08800099071873</tradeName>
    <deviceName>Long Engine Blade</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEB-SL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:33.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099071477</udiDi>
    <basicUdiDi>88000990CSBY2</basicUdiDi>
    <tradeName>08800099071477</tradeName>
    <deviceName>Blade for CMF Surgery</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEB-20C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:32.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099070005</udiDi>
    <basicUdiDi>88000990HDEXL</basicUdiDi>
    <tradeName>08800099070005</tradeName>
    <deviceName>Handle</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:28.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800091150316</udiDi>
    <basicUdiDi>88000911nugabestN4AJ</basicUdiDi>
    <tradeName>08800091150316</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nuga Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026434</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120622</emdnCode>
    <emdnDescription>MUSCLE STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N6-DM-13-02-000-01A-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:22.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800089800469</udiDi>
    <basicUdiDi>880008980046955</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>M9F34G</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:21.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800089800452</udiDi>
    <basicUdiDi>88000898004524L</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>M9F32G</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:20.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800089800407</udiDi>
    <basicUdiDi>88000898004074F</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-NDL9P32G3</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:19.195Z</lastUpdated>
  </row>
</eudamedExport>