<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="certificates">
  <row>
    <certificateNumber>HZ 2241408-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.reissued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>GE Medical Systems LLC</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000001632</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-06-26T00:00:00</issueDate>
    <expiryDate>2030-07-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:56.932Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2241427-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>GE Medical Systems Israel", Functional Imaging</manufacturerActorName>
    <manufacturerActorSrn>IL-MF-000003062</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-14T00:00:00</issueDate>
    <expiryDate>2027-09-19T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:56.880Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2247538-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Stryker Instruments</manufacturerActorName>
    <manufacturerActorSrn>US-MF-000025219</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-12T00:00:00</issueDate>
    <expiryDate>2031-02-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:56.847Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2343812-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Shenzhen MandeLab Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000009021</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-08-22T00:00:00</issueDate>
    <expiryDate>2027-03-16T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:56.643Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2367770-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Shenzhen Root Innovation Technology Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000035094</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-28T00:00:00</issueDate>
    <expiryDate>2031-05-27T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:56.522Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2467727-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.reissued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Guilin Kevin Peter Technology Co., Ltd.</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000022934</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-02-02T00:00:00</issueDate>
    <expiryDate>2030-01-23T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:56.406Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2678802-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.reissued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>bitop AG</manufacturerActorName>
    <manufacturerActorSrn>DE-MF-000006543</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-06-01T00:00:00</issueDate>
    <expiryDate>2029-02-26T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:50.039Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2693790-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>GA Health Company Limited</manufacturerActorName>
    <manufacturerActorSrn>HK-MF-000019784</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-06-02T00:00:00</issueDate>
    <expiryDate>2031-06-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:50.005Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>HZ 2709727-1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Hemolens Diagnostics Sp. z o.o.</manufacturerActorName>
    <manufacturerActorSrn>PL-MF-000016015</manufacturerActorSrn>
    <notifiedBodyNumber>0197</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-21T00:00:00</issueDate>
    <expiryDate>2031-05-20T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:49.906Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>IT321284</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.reissued</certificateStatus>
    <basicUdiDi>805894611ATC5H7</basicUdiDi>
    <manufacturerActorName>GPI S.P.A.</manufacturerActorName>
    <manufacturerActorSrn>IT-MF-000020127</manufacturerActorSrn>
    <notifiedBodyNumber>1370</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2023-02-23T00:00:00</issueDate>
    <expiryDate>2028-02-22T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:49.756Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>IT342456</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-assurance</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>ALMA s.r.l.</manufacturerActorName>
    <manufacturerActorSrn>IT-MF-000029690</manufacturerActorSrn>
    <notifiedBodyNumber>1370</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-11-06T00:00:00</issueDate>
    <expiryDate>2030-05-11T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-08T00:31:49.524Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>SCAR-9.2.1.4</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Tandem Health AB</manufacturerActorName>
    <manufacturerActorSrn>SE-MF-000049463</manufacturerActorSrn>
    <notifiedBodyNumber>3022</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-06-05T00:00:00</issueDate>
    <expiryDate>2031-02-15T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-06T11:03:11.587Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>SCAR-21.2.1.0</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>BrightHeart</manufacturerActorName>
    <manufacturerActorSrn>FR-MF-000044855</manufacturerActorSrn>
    <notifiedBodyNumber>3022</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-06-02T00:00:00</issueDate>
    <expiryDate>2031-06-01T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-06T10:05:24.098Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>MDR 00064-B</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.technical-documentation</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>843659383UTA423QE</basicUdiDi>
    <manufacturerActorName>Noventure S.L.U.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000000797</manufacturerActorSrn>
    <notifiedBodyNumber>0476</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-03-27T00:00:00</issueDate>
    <expiryDate>2029-11-14T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-05T09:10:57.934Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>MDR 00064-C</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.issued</certificateStatus>
    <basicUdiDi>843659383OLA923KZ</basicUdiDi>
    <manufacturerActorName>Noventure S.L.U.</manufacturerActorName>
    <manufacturerActorSrn>ES-MF-000000797</manufacturerActorSrn>
    <notifiedBodyNumber>0476</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2024-11-15T00:00:00</issueDate>
    <expiryDate>2029-11-14T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-05T09:10:57.818Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>ITH 1343248 1</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Hydra srl</manufacturerActorName>
    <manufacturerActorSrn>IT-MF-000029149</manufacturerActorSrn>
    <notifiedBodyNumber>1936</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-08T00:00:00</issueDate>
    <expiryDate>2028-02-02T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-06-04T11:09:37.112Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1068</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.amended</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Shandong Weigao Orthopaedic Device Company Limited.</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000019785</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-22T00:00:00</issueDate>
    <expiryDate>2028-04-07T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-30T12:23:05.119Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1069</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.supplemented</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Zhejiang Soudon Medical Technology Co.,Ltd</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000021047</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2026-05-18T00:00:00</issueDate>
    <expiryDate>2029-04-07T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-30T12:23:05.108Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1070</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.withdrawn</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Zhejiang Soudon Medical Technology Co.,Ltd</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000021047</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-04-08T00:00:00</issueDate>
    <expiryDate>2030-04-07T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-30T12:23:05.090Z</lastUpdated>
  </row>
  <row>
    <certificateNumber>M.2025.MDR.1079</certificateNumber>
    <certificateType>refdata.certificate-mdr-type.quality-management-system</certificateType>
    <certificateStatus>refdata.certificate-status.withdrawn</certificateStatus>
    <basicUdiDi></basicUdiDi>
    <manufacturerActorName>Shunmei Medical Co.,Ltd</manufacturerActorName>
    <manufacturerActorSrn>CN-MF-000001160</manufacturerActorSrn>
    <notifiedBodyNumber>2696</notifiedBodyNumber>
    <notifiedBodyActorSrn></notifiedBodyActorSrn>
    <issueDate>2025-05-16T00:00:00</issueDate>
    <expiryDate>2029-05-15T00:00:00</expiryDate>
    <latestVersion>true</latestVersion>
    <lastUpdated>2026-05-30T12:23:05.047Z</lastUpdated>
  </row>
</eudamedExport>