<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="certificates">
  <row>
    <certificateNumber>JP24/00000273</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>MIKASA X-RAY Co.,Ltd.</manufacturerActorName>
    <manufacturerActorSrn>JP-MF-000028549</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-10-01T00:00:00</issueDate>
    <expiryDate>2029-10-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:56.124Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>JP25/00000098</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <manufacturerActorName>Tokai Medical Products, Inc.</manufacturerActorName>
    <manufacturerActorSrn>JP-MF-000011106</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-22T00:00:00</issueDate>
    <expiryDate>2030-03-31T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:55.375Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>JP25/00000309</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>TOWA MEDICAL INSTRUMENTS CO.,LTD.</manufacturerActorName>
    <manufacturerActorSrn>JP-MF-000004196</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-10-15T00:00:00</issueDate>
    <expiryDate>2030-10-15T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:54.647Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>JP26/00000091</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Unisis Corporation</manufacturerActorName>
    <manufacturerActorSrn>JP-MF-000026339</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-03-20T00:00:00</issueDate>
    <expiryDate>2031-03-20T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:53.921Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR23/00000132</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>88092095983X6</basicUdiDi>
    <manufacturerActorName>InBody Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000011833</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-06-03T00:00:00</issueDate>
    <expiryDate>2028-08-09T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:53.828Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR23/00000139</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Medios Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000011624</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-01-09T00:00:00</issueDate>
    <expiryDate>2028-08-31T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:53.101Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR23/00000154</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>RF Medical Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000012647</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-07-01T00:00:00</issueDate>
    <expiryDate>2028-09-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:52.385Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000016</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>STARmed Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000008605</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-04-28T00:00:00</issueDate>
    <expiryDate>2029-02-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:51.657Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000021</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>951701ComfortCoughN6</basicUdiDi>
    <manufacturerActorName>SEOIL PACIFIC CORP.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000012478</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-29T00:00:00</issueDate>
    <expiryDate>2029-03-05T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:50.938Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000041</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>RET,Inc.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000014159</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-05-24T00:00:00</issueDate>
    <expiryDate>2029-05-24T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:50.168Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000045</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Taewoong Medical Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000007515</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-11-14T00:00:00</issueDate>
    <expiryDate>2029-06-11T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:49.456Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000065</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>INTEROJO INC.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000022687</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-09-02T00:00:00</issueDate>
    <expiryDate>2029-08-14T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:48.738Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000075</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Hansol Medical Co.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000023984</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-09-03T00:00:00</issueDate>
    <expiryDate>2029-09-03T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:48.060Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/00000078</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>LowTem Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000016177</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-11-18T00:00:00</issueDate>
    <expiryDate>2029-09-19T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:47.373Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR24/0000049</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>C-K DENTAL IND.CO.,LTD.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000022929</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-06-24T00:00:00</issueDate>
    <expiryDate>2029-06-24T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:46.682Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR25/00000035</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Mega Medical Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000008718</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-05-15T00:00:00</issueDate>
    <expiryDate>2030-03-05T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:45.989Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>KR25/00000036</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi>880929378001M8</basicUdiDi>
    <manufacturerActorName>RENOSEM Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>KR-MF-000023080</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-23T00:00:00</issueDate>
    <expiryDate>2030-03-07T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:45.236Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1066</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.reinstated</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>TERUMEDICAL SRL</manufacturerActorName>
    <manufacturerActorSrn>RO-MF-000029005</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-20T00:00:00</issueDate>
    <expiryDate>2029-03-19T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:44.480Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1067</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>EMD Medical Limited</manufacturerActorName>
    <manufacturerActorSrn>MT-MF-000030379</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-28T00:00:00</issueDate>
    <expiryDate>2030-03-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:43.689Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1071</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000001938</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-18T00:00:00</issueDate>
    <expiryDate>2028-04-08T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T13:07:42.698Z</lastUpdated>
  </row>
</eudamedExport>