<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="certificates">
  <row>
    <certificateNumber>2022-MDR/QS-021</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerActorName>
    <manufacturerActorSrn>SI-MF-000000126</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-21T00:00:00</issueDate>
    <expiryDate>2027-09-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:08.731Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-022</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>8588009103Mevacs9W</basicUdiDi>
    <manufacturerActorName>MEDIST, s.r.o.</manufacturerActorName>
    <manufacturerActorSrn>SK-MF-000004422</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-27T00:00:00</issueDate>
    <expiryDate>2027-09-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:08.643Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-023/A</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Shin poong Pharm Co.,Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000009206</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-10-06T00:00:00</issueDate>
    <expiryDate>2027-09-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:08.571Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-024</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>CHIRANA T.Injecta, a.s.</manufacturerActorName>
    <manufacturerActorSrn>SK-MF-000003702</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-30T00:00:00</issueDate>
    <expiryDate>2027-09-30T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:08.492Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-025</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>CHIRANA T.Injecta, a.s.</manufacturerActorName>
    <manufacturerActorSrn>SK-MF-000003702</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-30T00:00:00</issueDate>
    <expiryDate>2027-09-30T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:08.411Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-026</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>CHIRANA T.Injecta, a.s.</manufacturerActorName>
    <manufacturerActorSrn>SK-MF-000003702</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-30T00:00:00</issueDate>
    <expiryDate>2027-09-30T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:08.338Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-027</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>CHIRANA T.Injecta, a.s.</manufacturerActorName>
    <manufacturerActorSrn>SK-MF-000003702</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-30T00:00:00</issueDate>
    <expiryDate>2027-09-30T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:07.602Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/QS-028</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Neofyt spol. s r.o.</manufacturerActorName>
    <manufacturerActorSrn>CZ-MF-000017906</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-12-09T00:00:00</issueDate>
    <expiryDate>2027-12-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:06.828Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/TD-003/A</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>858602352MVYZ</basicUdiDi>
    <manufacturerActorName>MARTIKAN s.r.o.</manufacturerActorName>
    <manufacturerActorSrn>SK-MF-000005834</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-04-10T00:00:00</issueDate>
    <expiryDate>2027-07-20T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:06.072Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2022-MDR/TD-023/A</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>880610380654DV</basicUdiDi>
    <manufacturerActorName>Shin poong Pharm Co.,Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000009206</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-10-06T00:00:00</issueDate>
    <expiryDate>2027-09-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:06.002Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023 CR 0003</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>RGB MEDICAL DEVICES, S.A.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000023793</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-07-26T00:00:00</issueDate>
    <expiryDate>2028-07-25T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:04.390Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023 CR 0009</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>AJL OPHTHALMIC</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000000267</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-03-17T00:00:00</issueDate>
    <expiryDate>2028-11-20T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:03.479Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023 CR 0011</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Life Vascular Devices Biotech, S.L.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000019783</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-06-24T00:00:00</issueDate>
    <expiryDate>2028-12-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:03.410Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023 PR 0006</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</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>2024-10-14T00:00:00</issueDate>
    <expiryDate>2028-11-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:02.451Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023 PR 0007</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>OIARSO, S. COOP</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000000866</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-09-20T00:00:00</issueDate>
    <expiryDate>2028-11-05T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:01.596Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023 PR 0010</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>TEXTIL PLANAS OLIVERAS S.A.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000001830</manufacturerActorSrn>
    <notifiedBodyNumber>0318</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-11-27T00:00:00</issueDate>
    <expiryDate>2028-11-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:00.671Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023-MDR/QS-001</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>PANEP s.r.o.</manufacturerActorName>
    <manufacturerActorSrn>CZ-PR-000032922</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-01-25T00:00:00</issueDate>
    <expiryDate>2028-01-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:00.595Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023-MDR/QS-002</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>PANEP s.r.o.</manufacturerActorName>
    <manufacturerActorSrn>CZ-PR-000032922</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-01-25T00:00:00</issueDate>
    <expiryDate>2028-01-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:32:00.517Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023-MDR/QS-003</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>PANEP s.r.o.</manufacturerActorName>
    <manufacturerActorSrn>CZ-PR-000032922</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-01-25T00:00:00</issueDate>
    <expiryDate>2028-01-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:59.722Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>2023-MDR/QS-004/C</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>880936909BNC003HC</basicUdiDi>
    <manufacturerActorName>BNC KOREA, Inc.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000008321</manufacturerActorSrn>
    <notifiedBodyNumber>2265</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-11-11T00:00:00</issueDate>
    <expiryDate>2028-01-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:31:59.651Z</lastUpdated>
  </row>
</eudamedExport>