<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800099060723</udiDi>
    <basicUdiDi>B-08800099060723</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE-12</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSE-12-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:25.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060716</udiDi>
    <basicUdiDi>B-08800099060716</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE-10</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSE-10-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:24.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060709</udiDi>
    <basicUdiDi>B-08800099060709</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE-8</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSE-8-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:23.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060693</udiDi>
    <basicUdiDi>B-08800099060693</basicUdiDi>
    <tradeName>Maxillary skeletal expander</tradeName>
    <deviceName>MSE-6</deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSE-6-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:19.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055701110</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName>Non-Sterile Zirconia Block</deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZD9810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:18.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G359ED1460Q</udiDi>
    <basicUdiDi>++G359LigatureInstRR</basicUdiDi>
    <tradeName>Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIXDENT INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000027173</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-146</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:45:19.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G359ED1470R</udiDi>
    <basicUdiDi>++G359LigatureInstRR</basicUdiDi>
    <tradeName>Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIXDENT INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000027173</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-147</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:45:19.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G359ED1480S</udiDi>
    <basicUdiDi>++G359LigatureInstRR</basicUdiDi>
    <tradeName>Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIXDENT INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000027173</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-148</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:45:19.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G359ED1490T</udiDi>
    <basicUdiDi>++G359LigatureInstRR</basicUdiDi>
    <tradeName>Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIXDENT INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000027173</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-149</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:45:18.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G359ED1500L</udiDi>
    <basicUdiDi>++G359LigatureInstRR</basicUdiDi>
    <tradeName>Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIXDENT INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000027173</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:45:17.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055703701</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZDS9825-B3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055704722</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-D12-A2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055703350</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZDS9814-B2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055705101</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-Z14-A1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055703404</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZDS9824-B2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055703107</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZDS9822-B1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055705354</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-Z25-A3.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055705279</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-Z22-A3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055703121</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZDS9825-B1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800055703169</udiDi>
    <basicUdiDi>88000557ZIR2B</basicUdiDi>
    <tradeName>ARENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARUM DENTISTRY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009313</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020604</emdnCode>
    <emdnDescription>ORTHODONTIC DENTAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-ZD9814-B2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:32.390Z</lastUpdated>
  </row>
</eudamedExport>