<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800099060921</udiDi>
    <basicUdiDi>B-08800099060921</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>RPE-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>RPE-12-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:14.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060914</udiDi>
    <basicUdiDi>B-08800099060914</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>RPE-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>RPE-10-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:09.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060907</udiDi>
    <basicUdiDi>B-08800099060907</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>RPE-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>RPE-8-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:08.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060891</udiDi>
    <basicUdiDi>B-08800099060891</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>RPE-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>RPE-6-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:08.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060884</udiDi>
    <basicUdiDi>B-08800099060884</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE Ⅱ-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>KBE Ⅱ-12-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:07.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060877</udiDi>
    <basicUdiDi>B-08800099060877</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE Ⅱ-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>KBE Ⅱ-10-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:02.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060860</udiDi>
    <basicUdiDi>B-08800099060860</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE Ⅱ-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>KBE Ⅱ-8-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:01.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060853</udiDi>
    <basicUdiDi>B-08800099060853</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE Ⅱ-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>KBE Ⅱ-6-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:00.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060846</udiDi>
    <basicUdiDi>B-08800099060846</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE-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>KBE-12-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:25:00.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060839</udiDi>
    <basicUdiDi>B-08800099060839</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE-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>KBE-10-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:55.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060822</udiDi>
    <basicUdiDi>B-08800099060822</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE-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>KBE-8-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:55.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060815</udiDi>
    <basicUdiDi>B-08800099060815</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>KBE-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>KBE-6-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:53.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060808</udiDi>
    <basicUdiDi>B-08800099060808</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-12 F</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 Ⅱ-12 F-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:52.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060792</udiDi>
    <basicUdiDi>B-08800099060792</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-10 F</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 Ⅱ-10 F-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:48.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060785</udiDi>
    <basicUdiDi>B-08800099060785</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-8 F</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 Ⅱ-8 F-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:48.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060778</udiDi>
    <basicUdiDi>B-08800099060778</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-6 F</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 Ⅱ-6 F-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:32.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060761</udiDi>
    <basicUdiDi>B-08800099060761</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-12 E</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 Ⅱ-12 E-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:31.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060754</udiDi>
    <basicUdiDi>B-08800099060754</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-10 E</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 Ⅱ-10 E-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:31.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060747</udiDi>
    <basicUdiDi>B-08800099060747</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-8 E</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 Ⅱ-8 E-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:30.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099060730</udiDi>
    <basicUdiDi>B-08800099060730</basicUdiDi>
    <tradeName>Maxillary Skeletal Expander</tradeName>
    <deviceName>MSE Ⅱ-6 E</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 Ⅱ-6 E-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:26.337Z</lastUpdated>
  </row>
</eudamedExport>