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<eudamedExport entity="devices">
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    <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>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>
    <emdnCode>W0105011203</emdnCode>
    <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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    <udiDi>06974795550375</udiDi>
    <basicUdiDi>B-06974795550375</basicUdiDi>
    <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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    <udiDi>06974795550368</udiDi>
    <basicUdiDi>B-06974795550368</basicUdiDi>
    <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>
    <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>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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  <row>
    <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>
    <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-0096-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:57:51.830Z</lastUpdated>
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  <row>
    <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>
    <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-0041-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:19.695Z</lastUpdated>
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  <row>
    <udiDi>04049055000272</udiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:23.336Z</lastUpdated>
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    <udiDi>15420045510401</udiDi>
    <basicUdiDi>54200455DIAGPFMRSADE</basicUdiDi>
    <tradeName>Panther Fusion MRSA Assay</tradeName>
    <deviceName>Panther Fusion MRSA 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>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04803</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:18.958Z</lastUpdated>
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    <udiDi>04049095160028</udiDi>
    <basicUdiDi>4049095PG06050000EX</basicUdiDi>
    <tradeName>04049095160028</tradeName>
    <deviceName>RIDA®GENE MRSA</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG0605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:21.696Z</lastUpdated>
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  <row>
    <udiDi>04049055003662</udiDi>
    <basicUdiDi>40490550300001004TX</basicUdiDi>
    <tradeName>FluoroType® MRSA VER 3.0</tradeName>
    <deviceName>FluoroType® MRSA VER 3.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:56.323Z</lastUpdated>
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    <udiDi>08800111722219</udiDi>
    <basicUdiDi>88001117IPCA01MA22XG</basicUdiDi>
    <tradeName>STANDARD™ M10 MRSA/SA</tradeName>
    <deviceName>STANDARD™ M10 MRSA/SA</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11MSS10A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:33:09.207Z</lastUpdated>
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    <udiDi>15420045510449</udiDi>
    <basicUdiDi>54200455DIAGPFMRSADE</basicUdiDi>
    <tradeName>Panther Fusion MRSA Assay Controls</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>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04805</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.746Z</lastUpdated>
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