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    <tradeName>ResistancePlus MG (LC480)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010501080304</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:10.972Z</lastUpdated>
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    <udiDi>09352224001488</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG (7500)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010501080304</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:10.946Z</lastUpdated>
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    <udiDi>09352224001495</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG (CFX)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010501080304</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:10.924Z</lastUpdated>
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    <udiDi>15420045509160</udiDi>
    <basicUdiDi>54200455DIAGAPTMGENY9</basicUdiDi>
    <tradeName>Aptima Mycoplasma genitalium Assay Calibrators Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-03393</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T15:39:57.549Z</lastUpdated>
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    <udiDi>06973843227870</udiDi>
    <basicUdiDi>697384322BSJ09JS</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ09M1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:44.497Z</lastUpdated>
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  <row>
    <udiDi>06973843227887</udiDi>
    <basicUdiDi>697384322BSJ09JS</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ09S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:44.486Z</lastUpdated>
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