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    <tradeName>DIFCO</tradeName>
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    <tradeName>DIFCO</tradeName>
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    <tradeName>DIFCO</tradeName>
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    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <tradeName>KarbaDia Rapid Test</tradeName>
    <deviceName>KarbaDia Rapid Test</deviceName>
    <manufacturerName>GaDia SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031123</manufacturerSrn>
    <authorisedRepresentativeName>ER Egészségügyi, Kereskedelmi és Szolgáltató Kft.</authorisedRepresentativeName>
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    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAR-025</reference>
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    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert MRSA/SA Blood Culture Assay</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
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    <tradeName>Typhoid IgGIgM Rapid Test Device (serum/plasma/whole blood)</tradeName>
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    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T21:59:14.610Z</lastUpdated>
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    <udiDi>06975760470148</udiDi>
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    <tradeName>Sepsis pathogenic microorganism detection kit (digital PCR)</tradeName>
    <deviceName>Sepsis pathogenic microorganism detection kit (digital PCR)</deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0007</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:16.500Z</lastUpdated>
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    <udiDi>06975447582249</udiDi>
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    <tradeName>06975447582249</tradeName>
    <deviceName>Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus Drug-Resistance Gene  Detection Kit (PCR Fluorescence Probe Method)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080602</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0141-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:28.952Z</lastUpdated>
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    <udiDi>06975447582201</udiDi>
    <basicUdiDi>B-06975447582201</basicUdiDi>
    <tradeName>06975447582201</tradeName>
    <deviceName>Vancomycin-Resistant Enterococcus Gene (vanA, vanB) Detection Kit (PCR Fluorescence)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080604</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0142-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:22.559Z</lastUpdated>
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    <udiDi>06975400320048</udiDi>
    <basicUdiDi>B-06975400320048</basicUdiDi>
    <tradeName>VIUICK</tradeName>
    <deviceName>Diagnostic Kit for Ureaplasma Urealyticum DNA (Real-Time PCR Method)</deviceName>
    <manufacturerName>Guangzhou Viuick Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000017369</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:51.542Z</lastUpdated>
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    <udiDi>06975344570110</udiDi>
    <basicUdiDi>B-06975344570110</basicUdiDi>
    <tradeName>Carbapenemase Rapid Test Cassette -KPC/NDM/VIM/IMP/OXA-48</tradeName>
    <deviceName>Carbapenemase Rapid Test Cassette-KPC/NDM/VIM/IMP/OXA-48</deviceName>
    <manufacturerName>Tianjin Jianbo Biological Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040307</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6003</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:50.549Z</lastUpdated>
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    <basicUdiDi>B-06974674893210</basicUdiDi>
    <tradeName>Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)</tradeName>
    <deviceName>Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0193</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:31.184Z</lastUpdated>
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    <basicUdiDi>B-06974674892404</basicUdiDi>
    <tradeName>MP IgM FIA Kit</tradeName>
    <deviceName>MP IgM FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0070</reference>
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    <lastUpdated>2026-07-06T17:14:21.776Z</lastUpdated>
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    <tradeName>MP IgG FIA Kit</tradeName>
    <deviceName>MP IgG FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP IgG FIA Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:20.166Z</lastUpdated>
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    <tradeName>06974323019558</tradeName>
    <deviceName>Carbapenemase test cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:04:14.876Z</lastUpdated>
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    <tradeName>06974323019541</tradeName>
    <deviceName>Carbapenemase test cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:04:14.086Z</lastUpdated>
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    <tradeName>06974323019534</tradeName>
    <deviceName>Carbapenemase test cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:04:12.486Z</lastUpdated>
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    <tradeName>06974323012412</tradeName>
    <deviceName>Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Salmonella</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A513L-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:20.864Z</lastUpdated>
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