<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="certificates">
  <row>
    <certificateNumber>2024-MDR/TD-055/A</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi>880920101DALIMASCX</basicUdiDi>
    <manufacturerActorName>Dalim Tissen Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000020019</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-04-30T00:00:00</issueDate>
    <expiryDate>2029-09-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:30.698Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2024-MDR/TD-056/B</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi>880920101DALIMDTGNM</basicUdiDi>
    <manufacturerActorName>Dalim Tissen Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000020019</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-04-30T00:00:00</issueDate>
    <expiryDate>2029-09-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:29.977Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2024-MDR/TD-058/A</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>85917126010501VQ</basicUdiDi>
    <manufacturerActorName>MEDIN, a.s.</manufacturerActorName>
    <manufacturerActorSrn>CZ-MF-000012371</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-06-23T00:00:00</issueDate>
    <expiryDate>2029-10-25T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:29.903Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2024-MDR/TD-061/A</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Elixir Medical Corporation</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000013041</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-04-22T00:00:00</issueDate>
    <expiryDate>2029-11-08T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:29.817Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2024-MDR/TD-067/B</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi>880936647KM01MT</basicUdiDi>
    <manufacturerActorName>Samyang Biopharm Corporation</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000037085</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-05T00:00:00</issueDate>
    <expiryDate>2029-12-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:29.745Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2024-MDR/TD-068/B</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>880936647KF01LQ</basicUdiDi>
    <manufacturerActorName>Samyang Biopharm Corporation</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000037085</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-02-18T00:00:00</issueDate>
    <expiryDate>2029-12-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:29.672Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2024-MDR/TD-069/B</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>88062270SG01PP</basicUdiDi>
    <manufacturerActorName>Samyang Biopharm Corporation</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000037085</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-02-18T00:00:00</issueDate>
    <expiryDate>2029-12-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:28.746Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0043</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>UNION DENTAL S.A.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000003189</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-03-09T00:00:00</issueDate>
    <expiryDate>2030-02-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:27.970Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0045</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Iberhospitex, S.A.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000000160</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-04T00:00:00</issueDate>
    <expiryDate>2029-07-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:27.894Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0055</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Pragmatech AI Solutions</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000039516</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-07-03T00:00:00</issueDate>
    <expiryDate>2030-07-02T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:27.108Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0056</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>VEC MEDICAL SPAIN, S.L.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000002992</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-07-07T00:00:00</issueDate>
    <expiryDate>2030-07-06T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:26.314Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0057</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Laboratorio Aragó S.L.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000001958</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-03-11T00:00:00</issueDate>
    <expiryDate>2030-07-17T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:25.624Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0058</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Nippon Gases España S.L.U.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000004323</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-08-12T00:00:00</issueDate>
    <expiryDate>2030-08-11T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:24.755Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0059</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Nippon Gases Portugal</manufacturerActorName>
    <manufacturerActorSrn>PT-MF-000004891</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-08-12T00:00:00</issueDate>
    <expiryDate>2030-08-11T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:24.677Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 CR 0064</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>VISIONWINGS, S.L.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000021379</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-11-17T00:00:00</issueDate>
    <expiryDate>2030-11-16T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:23.924Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 DR 0044</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>779803446SpacersHipJM</basicUdiDi>
    <manufacturerActorName>Laboratorios SL S.A.</manufacturerActorName>
    <manufacturerActorSrn>AR-MF-000023153</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-02-27T00:00:00</issueDate>
    <expiryDate>2029-07-18T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:23.847Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025 PR 0060</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>CONÓPTICA, S.L.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000040465</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-23T00:00:00</issueDate>
    <expiryDate>2030-09-22T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:23.064Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025-IVDR/QS-001</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>8905459HIVOSF9V</basicUdiDi>
    <manufacturerActorName>Meril Diagnostics Pvt. Ltd.</manufacturerActorName>
    <manufacturerActorSrn>IN-MF-000028158</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-20T00:00:00</issueDate>
    <expiryDate>2028-09-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:22.988Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025-IVDR/QS-009</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>890600528cuphcgKG</basicUdiDi>
    <manufacturerActorName>Cupid Limited</manufacturerActorName>
    <manufacturerActorSrn>IN-MF-000033199</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-10-13T00:00:00</issueDate>
    <expiryDate>2030-10-13T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:22.911Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2025-IVDR/TD-001</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>8905459HIVOSF9V</basicUdiDi>
    <manufacturerActorName>Meril Diagnostics Pvt. Ltd.</manufacturerActorName>
    <manufacturerActorSrn>IN-MF-000028158</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-20T00:00:00</issueDate>
    <expiryDate>2028-09-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:22.818Z</lastUpdated>
  </row>
</eudamedExport>