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    <tradeName>MutaPLEX® PRE/RU/LA</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <deviceName>MutaPLEX® EU/BAC/BIF, PCR</deviceName>
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    <tradeName>MutaPLEX® AKM/FAEP, PCR</tradeName>
    <deviceName>MutaPLEX® AKM/FAEP, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>MutaPLEX® AKM/FAEP, PCR</tradeName>
    <deviceName>MutaPLEX® AKM/FAEP, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <udiDi>D-000012807194077RD</udiDi>
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    <tradeName>Carbapenem Resistance Gene Detection Kit(Fluorescence PCR)</tradeName>
    <deviceName>Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:51.691Z</lastUpdated>
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    <tradeName>OXA23 Carbapenemase Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>OXA23 Carbapenemase Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:45.963Z</lastUpdated>
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    <udiDi>D-000012807160083PB</udiDi>
    <basicUdiDi>B-000012807160083PB</basicUdiDi>
    <tradeName>Carbapenemase Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>Carbapenemase Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT085</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:43.571Z</lastUpdated>
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    <udiDi>08809240102886</udiDi>
    <basicUdiDi>924010MR10289KS</basicUdiDi>
    <tradeName>Allplex™ MDRO Assay</tradeName>
    <deviceName>Allplex™ MDRO Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MR10288Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:02:59.573Z</lastUpdated>
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    <udiDi>08908015304835</udiDi>
    <basicUdiDi>89080153043B1280L8</basicUdiDi>
    <tradeName>TRUPCR® Rifampicin &amp; Isoniazid Resistant MTB Detection Kit</tradeName>
    <deviceName>TRUPCR® Rifampicin &amp; Isoniazid Resistant MTB Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1280/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:14.240Z</lastUpdated>
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    <udiDi>08906213930429</udiDi>
    <basicUdiDi>89080153043B1283LE</basicUdiDi>
    <tradeName>TRUPCR® MRSA Real-Time PCR Detection kit</tradeName>
    <deviceName>TRUPCR® MRSA Real-Time PCR Detection kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080602</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1283/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:09.138Z</lastUpdated>
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    <udiDi>08906213930399</udiDi>
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    <tradeName>TRUPCR® UTI AST Panel Kit</tradeName>
    <deviceName>TRUPCR® UTI AST Panel Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T19:03:07.444Z</lastUpdated>
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    <tradeName>TRUPCR® AST Panel Kit</tradeName>
    <deviceName>TRUPCR® AST Panel Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
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    <tradeName>TRUPCR® Carbapenem Resistance Detection Kit</tradeName>
    <deviceName>TRUPCR® Carbapenem Resistance Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
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    <reference>3B289/C</reference>
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    <lastUpdated>2026-07-03T18:55:08.494Z</lastUpdated>
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    <tradeName>TRUPCR® UTI ID Panel Kit</tradeName>
    <deviceName>TRUPCR® UTI ID Panel Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B319/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:55:04.485Z</lastUpdated>
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    <tradeName>TRUPCR® VRE Detection Kit</tradeName>
    <deviceName>TRUPCR® VRE Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
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    <lastUpdated>2026-07-03T18:55:02.889Z</lastUpdated>
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    <tradeName>TRUPCR® Rifampicin Resistant MTB Detection Kit</tradeName>
    <deviceName>TRUPCR® Rifampicin Resistant MTB Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1281/C</reference>
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    <lastUpdated>2026-07-03T18:55:02.200Z</lastUpdated>
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    <basicUdiDi>868521452PCR150G3</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>Enterecoccus spp./Van A/B Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <emdnDescription>TARGETED RESISTANCE TESTS - OTHER</emdnDescription>
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    <reference>CFP150P25</reference>
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    <tradeName>ChainFor™</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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