<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="certificates">
  <row>
    <certificateNumber>HX 2699595-1</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>AIDA GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000040784</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-02-09T00:00:00</issueDate>
    <expiryDate>2031-02-08T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:48.797Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HX 7091840-1</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerActorName>
    <manufacturerActorSrn>GB-MF-000016339</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-07-07T00:00:00</issueDate>
    <expiryDate>2027-01-06T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:47.997Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HX 7091841-1</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Siemens Healthcare Diagnostics Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000016336</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-02-06T00:00:00</issueDate>
    <expiryDate>2026-10-26T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:47.910Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HX 7091956-1</certificateNumber>
    <certificateType>refdata.certificate-ivdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>CareDx AB</manufacturerActorName>
    <manufacturerActorSrn>SE-MF-000040995</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-09-24T00:00:00</issueDate>
    <expiryDate>2030-09-23T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:47.100Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1007442-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Leina-Werke GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000005358</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-01-17T00:00:00</issueDate>
    <expiryDate>2029-01-16T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:46.297Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1010771-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>URSAPHARM Arzneimittel GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000007748</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-07T00:00:00</issueDate>
    <expiryDate>2029-12-12T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:44.651Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1011391-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Löwenstein Medical SE &amp; Co. KG</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000006028</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-09-06T00:00:00</issueDate>
    <expiryDate>2028-09-05T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:43.864Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1011605-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Hager &amp; Werken GmbH &amp; Co. KG</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000004938</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-22T00:00:00</issueDate>
    <expiryDate>2031-05-21T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:43.118Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1012635-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Optovue, Inc.</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000018369</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-08-08T00:00:00</issueDate>
    <expiryDate>2027-11-10T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:42.358Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1015743-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Novanta Medical GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000005815</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-03-24T00:00:00</issueDate>
    <expiryDate>2030-02-04T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:41.597Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1023580-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Balton Sp. z o.o.</manufacturerActorName>
    <manufacturerActorSrn>PL-MF-000010568</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-12T00:00:00</issueDate>
    <expiryDate>2030-12-17T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:40.870Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1023871-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>"Biofaktor" Sp. z o. o.</manufacturerActorName>
    <manufacturerActorSrn>PL-MF-000027226</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-04-28T00:00:00</issueDate>
    <expiryDate>2031-02-05T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:40.121Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1023926-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerActorName>
    <manufacturerActorSrn>PL-MF-000010592</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-10-07T00:00:00</issueDate>
    <expiryDate>2029-04-08T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:39.359Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1023950-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>HTL-Strefa S.A.</manufacturerActorName>
    <manufacturerActorSrn>PL-MF-000002198</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-09-26T00:00:00</issueDate>
    <expiryDate>2029-08-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:37.429Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1032460-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>ASPEL Spółka Akcyjna</manufacturerActorName>
    <manufacturerActorSrn>PL-MF-000018796</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-01-21T00:00:00</issueDate>
    <expiryDate>2030-01-15T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:35.914Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1037386-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>INNOTERE GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000006515</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-06-02T00:00:00</issueDate>
    <expiryDate>2028-06-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:35.098Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1061119-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Technolas Perfect Vision GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000007094</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-01-26T00:00:00</issueDate>
    <expiryDate>2028-07-11T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:34.278Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1082891-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>MELAG Medizintechnik GmbH &amp; Co. KG</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000006703</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-05-22T00:00:00</issueDate>
    <expiryDate>2026-12-23T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:32.645Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1105628-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>E. HAHNENKRATT GmbH</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000007184</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-09-02T00:00:00</issueDate>
    <expiryDate>2027-07-05T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:30.955Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 1108110-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>BEGO Implant Systems GmbH &amp; Co. KG</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000005410</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2022-11-11T00:00:00</issueDate>
    <expiryDate>2026-10-04T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-24T21:19:30.218Z</lastUpdated>
  </row>
</eudamedExport>