<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00844868005650</udiDi>
    <basicUdiDi>844868ACHU</basicUdiDi>
    <tradeName>Certain®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZimVie US Corp LLC</manufacturerName>
    <manufacturerSrn>US-MF-000048255</manufacturerSrn>
    <authorisedRepresentativeName>ZimVie Spain S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000983</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IIIC75</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:55.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844868006299</udiDi>
    <basicUdiDi>844868ACHU</basicUdiDi>
    <tradeName>Certain®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZimVie US Corp LLC</manufacturerName>
    <manufacturerSrn>US-MF-000048255</manufacturerSrn>
    <authorisedRepresentativeName>ZimVie Spain S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000983</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMIC30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:53.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908018231015</udiDi>
    <basicUdiDi>89080182313006D</basicUdiDi>
    <tradeName>Prime ortho</tradeName>
    <deviceName>IPR Files</deviceName>
    <manufacturerName>Sawbros Industries Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016702</manufacturerSrn>
    <authorisedRepresentativeName>Meddevices Lifesciences B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000594</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAWB/PL-IPRF</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:43.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800303549174</udiDi>
    <basicUdiDi>880998831SBS1V5</basicUdiDi>
    <tradeName>Flag Scan Body Long Diamond Body Set</tradeName>
    <deviceName>Dental Scan Body</deviceName>
    <manufacturerName>HUB Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000049206</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AXFSBL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:02:59.724Z</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>08800038700109</udiDi>
    <basicUdiDi>880003870023AY</basicUdiDi>
    <tradeName>08800038700109</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGUVRS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:45.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700093</udiDi>
    <basicUdiDi>880003870022AW</basicUdiDi>
    <tradeName>08800038700093</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGS24</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:45.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700086</udiDi>
    <basicUdiDi>880003870021AU</basicUdiDi>
    <tradeName>08800038700086</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGS13</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:41.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700079</udiDi>
    <basicUdiDi>880003870020AS</basicUdiDi>
    <tradeName>08800038700079</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGFS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:40.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700062</udiDi>
    <basicUdiDi>880003870019B9</basicUdiDi>
    <tradeName>08800038700062</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGFM</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:39.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700055</udiDi>
    <basicUdiDi>880003870018B7</basicUdiDi>
    <tradeName>08800038700055</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGFL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:38.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700048</udiDi>
    <basicUdiDi>880003870017B5</basicUdiDi>
    <tradeName>08800038700048</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGA</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:34.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038700031</udiDi>
    <basicUdiDi>880003870016B3</basicUdiDi>
    <tradeName>08800038700031</tradeName>
    <deviceName>VAROGuide PreGuide</deviceName>
    <manufacturerName>DMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000016967</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAROGuide PreGuide PGM24</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:33.970Z</lastUpdated>
  </row>
</eudamedExport>