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    <basicUdiDi>B-00613745002231</basicUdiDi>
    <tradeName>ImmunoWELL JCV IgG Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenDx LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052622</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3810</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:36:46.337Z</lastUpdated>
  </row>
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    <udiDi>00613745000060</udiDi>
    <basicUdiDi>B-00613745000060</basicUdiDi>
    <tradeName>ImmunoFLOW Mycoplasma pneumoniae</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenDx LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052622</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:36:46.305Z</lastUpdated>
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    <udiDi>00613745000091</udiDi>
    <basicUdiDi>B-00613745000091</basicUdiDi>
    <tradeName>ImmunoFLOW Mycoplasma IgM Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenDx LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052622</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3925</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:36:46.280Z</lastUpdated>
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    <udiDi>00613745000145</udiDi>
    <basicUdiDi>B-00613745000145</basicUdiDi>
    <tradeName>ImmunoFLOW Negative Control - Mycoplasma IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenDx LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052622</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3921</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:36:46.258Z</lastUpdated>
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  <row>
    <udiDi>00613745031309</udiDi>
    <basicUdiDi>B-00613745031309</basicUdiDi>
    <tradeName>ImmunoWELL Mycoplasma Pneumoniae (IgM Antibody)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenDx LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052622</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:36:46.240Z</lastUpdated>
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  <row>
    <udiDi>00613745031200</udiDi>
    <basicUdiDi>B-00613745031200</basicUdiDi>
    <tradeName>ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenDx LLC</manufacturerName>
    <manufacturerSrn>US-MF-000052622</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:36:46.211Z</lastUpdated>
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