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    <tradeName>VITEK® 2 COMPACT</tradeName>
    <deviceName>VITEK® 2 COMPACT</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27530</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:22.623Z</lastUpdated>
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    <udiDi>03573026111731</udiDi>
    <basicUdiDi>357302BUDI000290TF</basicUdiDi>
    <tradeName>DENSITOMETER DENSIMAT</tradeName>
    <deviceName>DENSITOMETER DENSIMAT</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99234</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:21.025Z</lastUpdated>
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    <udiDi>06938010900567</udiDi>
    <basicUdiDi>69380109005504U</basicUdiDi>
    <tradeName>06938010900567</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-360</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.771Z</lastUpdated>
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    <udiDi>06938010900574</udiDi>
    <basicUdiDi>69380109005504U</basicUdiDi>
    <tradeName>06938010900574</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-600</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.746Z</lastUpdated>
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    <udiDi>06938010900581</udiDi>
    <basicUdiDi>69380109005504U</basicUdiDi>
    <tradeName>06938010900581</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-660</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.728Z</lastUpdated>
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    <udiDi>03573026631017</udiDi>
    <basicUdiDi>357302BUDI002350TN</basicUdiDi>
    <tradeName>VITEK® PRO</tradeName>
    <deviceName>VITEK® PRO</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:50:59.000Z</lastUpdated>
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    <udiDi>00382904436247</udiDi>
    <basicUdiDi>038290XCFFNYWADK</basicUdiDi>
    <tradeName>Phoenix</tradeName>
    <deviceName>BD Phoenix™ M50 Automated Microbiology System</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443624</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:44:00.340Z</lastUpdated>
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    <udiDi>D-PartNumberC2416777</udiDi>
    <basicUdiDi>B-PartNumberC2416777</basicUdiDi>
    <tradeName>LabPro Connect v5.0 System (MR)</tradeName>
    <deviceName>LabPro Connect v5.0 System (MR)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010182</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24167</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:12:23.836Z</lastUpdated>
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    <udiDi>D-PartNumberB1016-139XT</udiDi>
    <basicUdiDi>B-PartNumberB1016-139XT</basicUdiDi>
    <tradeName>MicroScan Pos Combo Panel Type 31</tradeName>
    <deviceName>MicroScan Pos Combo Panel Type 31</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-139</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:12:19.833Z</lastUpdated>
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    <udiDi>D-C80309VS</udiDi>
    <basicUdiDi>B-C80309VS</basicUdiDi>
    <tradeName>MicroScan Pos Combo Panel Type 49</tradeName>
    <deviceName>MicroScan Pos Combo Panel Type 49</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80309</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:25.947Z</lastUpdated>
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    <udiDi>D-C80308VQ</udiDi>
    <basicUdiDi>B-C80308VQ</basicUdiDi>
    <tradeName>MicroScan Pos Combo Panel Type 48</tradeName>
    <deviceName>MicroScan Pos Combo Panel Type 48</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80308</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:21.943Z</lastUpdated>
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    <udiDi>D-C80307VN</udiDi>
    <basicUdiDi>B-C80307VN</basicUdiDi>
    <tradeName>MicroScan Pos MIC 40</tradeName>
    <deviceName>MicroScan Pos MIC 40</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80307</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:21.141Z</lastUpdated>
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    <udiDi>D-C80306VL</udiDi>
    <basicUdiDi>B-C80306VL</basicUdiDi>
    <tradeName>MicroScan Neg MDR Combo 100</tradeName>
    <deviceName>MicroScan Neg MDR Combo 100</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80306</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:20.352Z</lastUpdated>
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    <udiDi>D-C80305VJ</udiDi>
    <basicUdiDi>B-C80305VJ</basicUdiDi>
    <tradeName>MicroScan Neg Breakpoint Combo 53</tradeName>
    <deviceName>MicroScan Neg Breakpoint Combo 53</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80305</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:19.542Z</lastUpdated>
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    <udiDi>D-C80304VG</udiDi>
    <basicUdiDi>B-C80304VG</basicUdiDi>
    <tradeName>MicroScan Neg Combo 99</tradeName>
    <deviceName>MicroScan Neg Combo 99</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80304</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:15.541Z</lastUpdated>
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    <udiDi>D-C80303VE</udiDi>
    <basicUdiDi>B-C80303VE</basicUdiDi>
    <tradeName>MicroScan Neg Urine Combo Panel Type 98</tradeName>
    <deviceName>MicroScan Neg Urine Combo Panel Type 98</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80303</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:14.735Z</lastUpdated>
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    <udiDi>D-C80302VC</udiDi>
    <basicUdiDi>B-C80302VC</basicUdiDi>
    <tradeName>MicroScan Neg Multidrug Resistant MIC 2</tradeName>
    <deviceName>MicroScan Neg Multidrug Resistant MIC 2</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80302</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:13.939Z</lastUpdated>
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    <udiDi>D-C80301VA</udiDi>
    <basicUdiDi>B-C80301VA</basicUdiDi>
    <tradeName>MicroScan Negative MIC NF 64</tradeName>
    <deviceName>MicroScan Negative MIC NF 64</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80301</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:13.138Z</lastUpdated>
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    <udiDi>D-C80300V8</udiDi>
    <basicUdiDi>B-C80300V8</basicUdiDi>
    <tradeName>MicroScan Neg MIC Panel Type 63</tradeName>
    <deviceName>MicroScan Neg MIC Panel Type 63</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:09.148Z</lastUpdated>
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    <udiDi>D-C80299WG</udiDi>
    <basicUdiDi>B-C80299WG</basicUdiDi>
    <tradeName>MicroScan Neg MIC Panel Type 62</tradeName>
    <deviceName>MicroScan Neg MIC Panel Type 62</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80299</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:08.336Z</lastUpdated>
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