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    <basicUdiDi>69506174IM441040D7</basicUdiDi>
    <tradeName>06950617416487</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:46:08.375Z</lastUpdated>
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    <udiDi>06950617416470</udiDi>
    <basicUdiDi>69506174IM441041D9</basicUdiDi>
    <tradeName>06950617416470</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:46:02.368Z</lastUpdated>
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    <udiDi>06950617416449</udiDi>
    <basicUdiDi>69506174IM441041D9</basicUdiDi>
    <tradeName>06950617416449</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:46:01.165Z</lastUpdated>
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    <udiDi>06950617416395</udiDi>
    <basicUdiDi>69506174IM441041D9</basicUdiDi>
    <tradeName>06950617416395</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:59.983Z</lastUpdated>
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    <udiDi>06950617411611</udiDi>
    <basicUdiDi>69506174IM441041D9</basicUdiDi>
    <tradeName>06950617411611</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:10.746Z</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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <udiDi>09352224001433</udiDi>
    <basicUdiDi>9352224020001W6</basicUdiDi>
    <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>06942293581801</udiDi>
    <basicUdiDi>697518250G118353G</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae IgM Rapid Test  Kit</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Rapid Test  Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11835</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:51.288Z</lastUpdated>
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    <udiDi>06936155803835</udiDi>
    <basicUdiDi>B-06936155803835</basicUdiDi>
    <tradeName>Rapid Mycoplasma Pneumoniae IgM test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP15001-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:49.928Z</lastUpdated>
  </row>
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    <udiDi>06933260207985</udiDi>
    <basicUdiDi>B-06933260207985</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae Antigen Rapid Qualitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:03.976Z</lastUpdated>
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    <udiDi>06933260207978</udiDi>
    <basicUdiDi>B-06933260207978</basicUdiDi>
    <tradeName>Mycoplasmal Pneumonia IgM Rapid Qualitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:02.897Z</lastUpdated>
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