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<eudamedExport entity="devices">
  <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>08809744960005</udiDi>
    <basicUdiDi>B-08809744960005</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1207-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960104</udiDi>
    <basicUdiDi>B-08809744960104</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1208-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960203</udiDi>
    <basicUdiDi>B-08809744960203</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1507-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960302</udiDi>
    <basicUdiDi>B-08809744960302</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1508-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960401</udiDi>
    <basicUdiDi>B-08809744960401</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1509-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960500</udiDi>
    <basicUdiDi>B-08809744960500</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1511-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960609</udiDi>
    <basicUdiDi>B-08809744960609</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1513-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960708</udiDi>
    <basicUdiDi>B-08809744960708</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1517-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960807</udiDi>
    <basicUdiDi>B-08809744960807</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1365-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744960906</udiDi>
    <basicUdiDi>B-08809744960906</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1375-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744961002</udiDi>
    <basicUdiDi>B-08809744961002</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1808-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809744961101</udiDi>
    <basicUdiDi>B-08809744961101</basicUdiDi>
    <tradeName>Orthodontic Anchor Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaterials Korea, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019882</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAS-T1809-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.082Z</lastUpdated>
  </row>
</eudamedExport>