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    <tradeName>RIDA®Plex Staphylococcus Typing 8 well Step 1</tradeName>
    <deviceName>RIDA®Plex Staphylococcus Typing 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>21341S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:44:52.062Z</lastUpdated>
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    <udiDi>09343044006494</udiDi>
    <basicUdiDi>B-09343044006494</basicUdiDi>
    <tradeName>RIDA®Plex Staphylococcus Typing 8 well Step 2</tradeName>
    <deviceName>RIDA®Plex Staphylococcus Typing 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
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    <lastUpdated>2026-07-10T20:44:51.251Z</lastUpdated>
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    <udiDi>09343044002700</udiDi>
    <basicUdiDi>B-09343044002700</basicUdiDi>
    <tradeName>Staphylococcus typing 8-well</tradeName>
    <deviceName>Step 1 tubes for Staphylococcus typing 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>09343044002694</udiDi>
    <basicUdiDi>B-09343044002694</basicUdiDi>
    <tradeName>Staphylococcus typing 8-well</tradeName>
    <deviceName>Step 2 Plates for Staphylococcus typing 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21341P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:48.055Z</lastUpdated>
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    <udiDi>08885013953077</udiDi>
    <basicUdiDi>B-08885013953077</basicUdiDi>
    <tradeName>Sentosa SA Direct MRSA/SA PCR Test (4x24)</tradeName>
    <deviceName>Sentosa SA Direct MRSA/SA PCR Test (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300247</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:16:51.481Z</lastUpdated>
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    <udiDi>00382902409168</udiDi>
    <basicUdiDi>038290QUHMNYFQML</basicUdiDi>
    <tradeName>BBL STAPHYLOSLIDE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240916</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>06974858560853</udiDi>
    <basicUdiDi>B-06974858560853</basicUdiDi>
    <tradeName>06974858560853</tradeName>
    <deviceName>Staphylococcus Aureus DNA Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P057H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:05.008Z</lastUpdated>
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    <tradeName>06974795550375</tradeName>
    <deviceName>Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10200163B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:05.752Z</lastUpdated>
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    <tradeName>06974795550368</tradeName>
    <deviceName>Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10200163A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:04.953Z</lastUpdated>
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    <udiDi>06974767392040</udiDi>
    <basicUdiDi>B-06974767392040</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE MRSA&amp;SA Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018020402-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:10.356Z</lastUpdated>
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    <udiDi>06974767391548</udiDi>
    <basicUdiDi>B-06974767391548</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE MRSA&amp;SA Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018020405-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:37.481Z</lastUpdated>
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    <udiDi>06971042227219</udiDi>
    <basicUdiDi>B-06971042227219</basicUdiDi>
    <tradeName>Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit</tradeName>
    <deviceName>Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0125-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:58:00.021Z</lastUpdated>
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    <udiDi>06971042227172</udiDi>
    <basicUdiDi>B-06971042227172</basicUdiDi>
    <tradeName>Methicillin-resistant Staphylococcus Aureus (MRSA) Real Time PCR Kit</tradeName>
    <deviceName>Methicillin-resistant Staphylococcus Aureus (MRSA) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0096-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:57:51.830Z</lastUpdated>
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    <udiDi>06971042224805</udiDi>
    <basicUdiDi>B-06971042224805</basicUdiDi>
    <tradeName>Staphylococcus Aureus Real Time PCR Kit</tradeName>
    <deviceName>Staphylococcus Aureus Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-0041-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:19.695Z</lastUpdated>
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    <basicUdiDi>B-04049095160042</basicUdiDi>
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    <deviceName>RIDA®GENE PVL</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG0645</reference>
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    <basicUdiDi>B-04049055000272</basicUdiDi>
    <tradeName>GenoType MRSA VER 3.0</tradeName>
    <deviceName>GenoType MRSA VER 3.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>30512</reference>
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    <lastUpdated>2026-07-06T00:03:23.336Z</lastUpdated>
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    <tradeName>COAGULASE PLASMA 5ML</tradeName>
    <deviceName>COAGULASE PLASMA</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
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    <tradeName>Panther Fusion MRSA Assay</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04803</reference>
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    <lastUpdated>2026-07-02T01:06:18.958Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>62596</reference>
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    <lastUpdated>2026-07-01T15:47:56.323Z</lastUpdated>
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