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    <tradeName>Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT024</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:17.237Z</lastUpdated>
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    <udiDi>09352224000016</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG</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>20001L-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:11.153Z</lastUpdated>
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    <udiDi>06973843227801</udiDi>
    <basicUdiDi>697384322BSJ09JS</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)</tradeName>
    <deviceName>Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)</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>BSJ09L1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:02:09.571Z</lastUpdated>
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    <udiDi>15420045509146</udiDi>
    <basicUdiDi>54200455DIAGAPTMGENY9</basicUdiDi>
    <tradeName>Aptima Mycoplasma genitalium Assay</tradeName>
    <deviceName>Aptima Mycoplasma genitalium Assay</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-03374</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:12.577Z</lastUpdated>
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    <udiDi>08595696300326</udiDi>
    <basicUdiDi>859569630010Q4</basicUdiDi>
    <tradeName>GeneProof Mycoplasma genitalium/hominis PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium/hominis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MGH/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:58:58.111Z</lastUpdated>
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    <udiDi>08595696300319</udiDi>
    <basicUdiDi>859569630010Q4</basicUdiDi>
    <tradeName>GeneProof Mycoplasma genitalium/hominis PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium/hominis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MGH/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:58:52.111Z</lastUpdated>
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    <udiDi>06973492240213</udiDi>
    <basicUdiDi>697349224U2030032C000F5</basicUdiDi>
    <tradeName>EasyNAT UU Assay</tradeName>
    <deviceName>EasyNAT UU Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:31.626Z</lastUpdated>
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    <udiDi>06973492240169</udiDi>
    <basicUdiDi>697349224U2020012C000DL</basicUdiDi>
    <tradeName>EasyNAT MP Assay</tradeName>
    <deviceName>EasyNAT MP Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:23.236Z</lastUpdated>
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    <udiDi>06973492240145</udiDi>
    <basicUdiDi>697349224U2030022C000EQ</basicUdiDi>
    <tradeName>EasyNAT MG Assay</tradeName>
    <deviceName>EasyNAT MG Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:20.825Z</lastUpdated>
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    <udiDi>15420045509153</udiDi>
    <basicUdiDi>54200455DIAGAPTMGENY9</basicUdiDi>
    <tradeName>Aptima Mycoplasma genitalium Assay</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-03374</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.425Z</lastUpdated>
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    <udiDi>06955792731011</udiDi>
    <basicUdiDi>B-06955792731011</basicUdiDi>
    <tradeName>06955792731011</tradeName>
    <deviceName>Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3016E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:39.528Z</lastUpdated>
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  <row>
    <udiDi>06955792731004</udiDi>
    <basicUdiDi>B-06955792731004</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3016E</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:36.904Z</lastUpdated>
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    <udiDi>09352224000023</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG(550)</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>2000201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.334Z</lastUpdated>
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    <udiDi>09352224000047</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG Positive Control</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>95001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.282Z</lastUpdated>
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    <udiDi>09352224000191</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG(675)</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>2000301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.229Z</lastUpdated>
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    <udiDi>09352224000207</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG</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>2000125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.207Z</lastUpdated>
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    <udiDi>09352224000214</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG(550)</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>2000225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.185Z</lastUpdated>
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    <udiDi>09352224000221</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG(675)</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>2000325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.165Z</lastUpdated>
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    <udiDi>09352224000382</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG FleXible</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>S2A-2000410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.122Z</lastUpdated>
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    <udiDi>09352224000399</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <tradeName>ResistancePlus MG S2A Positive Control</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>S2A-95004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:25:11.099Z</lastUpdated>
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