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<eudamedExport entity="devices">
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    <basicUdiDi>B-00685447018568</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:03.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447018551</udiDi>
    <basicUdiDi>B-00685447018551</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:59.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447018544</udiDi>
    <basicUdiDi>B-00685447018544</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:59.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447004592</udiDi>
    <basicUdiDi>B-00685447004592</basicUdiDi>
    <tradeName>00685447004592</tradeName>
    <deviceName>RFP-100A Connector Cables</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0317</emdnCode>
    <emdnDescription>GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFX-BAY-TS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:58.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447000969</udiDi>
    <basicUdiDi>B-00685447000969</basicUdiDi>
    <tradeName>00685447000969</tradeName>
    <deviceName>Baylis Medical Company Radiofrequency Puncture Generator</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010999</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFP-100A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:57.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447000594</udiDi>
    <basicUdiDi>06854470002PN</basicUdiDi>
    <tradeName>00685447000594</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFA-FS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:00:31.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447001096</udiDi>
    <basicUdiDi>06854470001PL</basicUdiDi>
    <tradeName>DuoMode™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFX-BAY-DUO-100A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:00:30.989Z</lastUpdated>
  </row>
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