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    <tradeName>Xpert®</tradeName>
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    <manufacturerName>Cepheid</manufacturerName>
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    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
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    <tradeName>Xpert®</tradeName>
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    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA</emdnDescription>
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    <tradeName>Xpert®</tradeName>
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    <manufacturerName>Cepheid AB</manufacturerName>
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    <tradeName>Femoflor® 16</tradeName>
    <deviceName>Femoflor® 16 REAL-TIME PCR Detection Kit</deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1-P801-S3/6EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:34:14.610Z</lastUpdated>
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    <udiDi>D-G2M707521G5</udiDi>
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    <tradeName>MDR-Q Real-Time PCR Kit</tradeName>
    <deviceName>MDR-Q Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M707521,G2M707521R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:13.919Z</lastUpdated>
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    <tradeName>Sentosa SA vanA/vanB PCR Test</tradeName>
    <deviceName>Sentosa SA vanA/vanB PCR Test</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300015, 300016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:39.060Z</lastUpdated>
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    <udiDi>D-8683079717486E6</udiDi>
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    <tradeName>RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit</tradeName>
    <deviceName>RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202207-100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:23:30.072Z</lastUpdated>
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    <tradeName>RIDA®Plex CRE EU 16 well Step 1</tradeName>
    <deviceName>RIDA®Plex CRE EU 16 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21099S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:44:46.279Z</lastUpdated>
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    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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