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    <tradeName>CRE 16-well</tradeName>
    <deviceName>Step 1 tubes for CRE 16-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>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21098S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:21.125Z</lastUpdated>
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    <udiDi>09343044002199</udiDi>
    <basicUdiDi>B-09343044002199</basicUdiDi>
    <tradeName>CRE 16-well</tradeName>
    <deviceName>Step 2 Plates for CRE 16-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <lastUpdated>2026-07-10T20:42:17.122Z</lastUpdated>
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    <udiDi>08809240103845</udiDi>
    <basicUdiDi>B-08809240103845</basicUdiDi>
    <tradeName>Allplex™ Entero-DR Assay</tradeName>
    <deviceName>Allplex™ Entero-DR Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR10384Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:54.792Z</lastUpdated>
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    <udiDi>08809240101070</udiDi>
    <basicUdiDi>B-08809240101070</basicUdiDi>
    <tradeName>Allplex™ Entero-DR Assay</tradeName>
    <deviceName>Allplex™ Entero-DR Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</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>CR9700X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:51.027Z</lastUpdated>
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    <udiDi>08809240101063</udiDi>
    <basicUdiDi>B-08809240101063</basicUdiDi>
    <tradeName>Allplex™ Entero-DR Assay</tradeName>
    <deviceName>Allplex™ Entero-DR 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR9700Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:32.565Z</lastUpdated>
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    <udiDi>08719327498002</udiDi>
    <basicUdiDi>B-08719327498002</basicUdiDi>
    <tradeName>DermaGenius® Resistance Multiplex real-time PCR kit</tradeName>
    <deviceName>DermaGenius® Resistance Multiplex real-time PCR kit</deviceName>
    <manufacturerName>PathoNostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>PN-303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:49.798Z</lastUpdated>
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    <udiDi>08698898740539</udiDi>
    <basicUdiDi>B-08698898740539</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion VRE QLP 1.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080604</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0630102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:00.459Z</lastUpdated>
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    <udiDi>08594161955610</udiDi>
    <basicUdiDi>B-08594161955610</basicUdiDi>
    <tradeName>GeneProof VRE PCR Kit</tradeName>
    <deviceName>GeneProof VRE PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080604</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRE/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:40.080Z</lastUpdated>
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    <udiDi>08594161955597</udiDi>
    <basicUdiDi>B-08594161955597</basicUdiDi>
    <tradeName>GeneProof VRE PCR Kit</tradeName>
    <deviceName>GeneProof VRE PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080604</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRE/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:38.488Z</lastUpdated>
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    <udiDi>07332940000134</udiDi>
    <basicUdiDi>B-07332940000134</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert MRSA/SA Blood Culture Assay</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GXMRSA/SA-BC-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:14.441Z</lastUpdated>
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    <udiDi>06975760470148</udiDi>
    <basicUdiDi>B-06975760470148</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080601</emdnCode>
    <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>
    <basicUdiDi>B-06975447582249</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <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>06974323012412</udiDi>
    <basicUdiDi>B-06974323012412</basicUdiDi>
    <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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    <udiDi>06974323012405</udiDi>
    <basicUdiDi>B-06974323012405</basicUdiDi>
    <tradeName>06974323012405</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-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:19.252Z</lastUpdated>
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    <udiDi>06974323012399</udiDi>
    <basicUdiDi>B-06974323012399</basicUdiDi>
    <tradeName>06974323012399</tradeName>
    <deviceName>Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Polymyxin</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>A7388-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:16.855Z</lastUpdated>
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    <tradeName>06974323012382</tradeName>
    <deviceName>Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Polymyxin</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7388-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:15.265Z</lastUpdated>
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    <tradeName>06974323011569</tradeName>
    <deviceName>Multiple Real-Time PCR Detection Kit for Carbapenem-resistant Gene</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>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:47.023Z</lastUpdated>
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    <tradeName>06974323011552</tradeName>
    <deviceName>Multiple Real-Time PCR Detection Kit for Carbapenem-resistant Gene</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>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:46.338Z</lastUpdated>
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    <udiDi>04050598008755</udiDi>
    <basicUdiDi>B-04050598008755</basicUdiDi>
    <tradeName>MutaPLEX MRSA seqc, PCR</tradeName>
    <deviceName>MutaPLEX MRSA seqc, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>KG194196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:46.080Z</lastUpdated>
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