<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="certificates">
  <row>
    <certificateNumber>TW25/00000808</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.restricted</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Crystalvue Medical Corporation</manufacturerActorName>
    <manufacturerActorSrn>TW-MF-000018351</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-22T00:00:00</issueDate>
    <expiryDate>2030-09-04T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:27.795Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>TW25/00000817</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Aco Healthcare Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>TW-MF-000034057</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-23T00:00:00</issueDate>
    <expiryDate>2030-09-23T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:27.093Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>TW25/00000878</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.restricted</certificateStatus>
    <basicUdiDi>47198751555ML3</basicUdiDi>
    <manufacturerActorName>ST. Shine Optical Co.,Ltd.</manufacturerActorName>
    <manufacturerActorSrn>TW-MF-000008432</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-26T00:00:00</issueDate>
    <expiryDate>2030-09-19T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:27.005Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>TW26/00000035</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Well-Life Healthcare Ltd.</manufacturerActorName>
    <manufacturerActorSrn>TW-MF-000011140</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-22T00:00:00</issueDate>
    <expiryDate>2031-01-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:26.308Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US22/00000080</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.cancelled</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Invacare Corporation</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000015762</manufacturerActorSrn>
    <notifiedBodyNumber>0598</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-23T00:00:00</issueDate>
    <expiryDate>2027-09-22T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:25.578Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US23/00000342</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Reliance Orthodontic Products, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000013812</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-08-10T00:00:00</issueDate>
    <expiryDate>2028-07-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:24.871Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US23/00000397</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>TMRW Life Sciences, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000013756</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-10-25T00:00:00</issueDate>
    <expiryDate>2028-09-06T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:24.180Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US24/00000111</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Radialogica LLC</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000037527</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-03-21T00:00:00</issueDate>
    <expiryDate>2029-03-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:23.470Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US24/00000159</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Merge Healthcare Incorporated</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000001275</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-20T00:00:00</issueDate>
    <expiryDate>2029-04-29T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:22.803Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US24/00000498</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>NuMED, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000010948</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-03-23T00:00:00</issueDate>
    <expiryDate>2029-12-06T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:22.706Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000029</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Tracey Technologies</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000027372</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-02-24T00:00:00</issueDate>
    <expiryDate>2030-01-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:22.027Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000108</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>INVIA</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000008976</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-05-02T00:00:00</issueDate>
    <expiryDate>2030-03-18T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:21.297Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000138</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Anumana, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000040309</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-07T00:00:00</issueDate>
    <expiryDate>2030-04-02T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:20.580Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000211</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000016778</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-12-31T00:00:00</issueDate>
    <expiryDate>2030-05-19T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:19.859Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000233</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>GT Metabolic Solutions, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000032479</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-05-30T00:00:00</issueDate>
    <expiryDate>2030-05-30T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:19.151Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000280</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Graham Medical Technologies, LLC</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000008507</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-07-08T00:00:00</issueDate>
    <expiryDate>2030-07-08T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:18.455Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000317</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Erchonia Corporation</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000003834</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-08-06T00:00:00</issueDate>
    <expiryDate>2030-08-06T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:17.751Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000348 1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>MedOne Surgical, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000002763</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-01T00:00:00</issueDate>
    <expiryDate>2030-09-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:17.035Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000376</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Overjet, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000039476</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-18T00:00:00</issueDate>
    <expiryDate>2030-09-18T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:22:16.311Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>US25/00000387</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Batrik Medical Manufacturing Inc.</manufacturerActorName>
    <manufacturerActorSrn>CA-MF-000007738</manufacturerActorSrn>
    <notifiedBodyNumber>1639</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-23T00:00:00</issueDate>
    <expiryDate>2030-09-23T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-23T23:12:15.207Z</lastUpdated>
  </row>
</eudamedExport>