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<eudamedExport entity="devices">
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    <udiDi>00850027856612</udiDi>
    <basicUdiDi>B-00850027856612</basicUdiDi>
    <tradeName>HVRe Influenza/RSV/SARS-CoV-2</tradeName>
    <deviceName>Fluxergy HVRe Influenza/RSV/ SARS-CoV-2</deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:47.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850027856605</udiDi>
    <basicUdiDi>B-00850027856605</basicUdiDi>
    <tradeName>HVRe Influenza/RSV/SARS-CoV-2</tradeName>
    <deviceName>Fluxergy HVRe Influenza/RSV/ SARS-CoV-2</deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:43.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850027856094</udiDi>
    <basicUdiDi>B-00850027856094</basicUdiDi>
    <tradeName>Fluxergy Reaction Mix COVID-19</tradeName>
    <deviceName>Fluxergy Reaction Mix COVID-19</deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>4155-CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:42.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850027856124</udiDi>
    <basicUdiDi>0850027856MkD6W</basicUdiDi>
    <tradeName>Fluxergy Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5506-CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:41.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850027856544</udiDi>
    <basicUdiDi>0850027856MkTC5F</basicUdiDi>
    <tradeName>00850027856544</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:41.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850027856636</udiDi>
    <basicUdiDi>0850027856MkSC5C</basicUdiDi>
    <tradeName>00850027856636</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:41.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850027856643</udiDi>
    <basicUdiDi>0850027856MkSC5C</basicUdiDi>
    <tradeName>00850027856643</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:41.872Z</lastUpdated>
  </row>
</eudamedExport>