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    <tradeName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:39.338Z</lastUpdated>
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    <udiDi>04251557100910</udiDi>
    <basicUdiDi>B-04251557100910</basicUdiDi>
    <tradeName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:38.535Z</lastUpdated>
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    <udiDi>04251557100903</udiDi>
    <basicUdiDi>B-04251557100903</basicUdiDi>
    <tradeName>04251557100903</tradeName>
    <deviceName>Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:34.531Z</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>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>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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