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    <tradeName>MicroScan Pos Combo Panel Type 37</tradeName>
    <deviceName>MicroScan Pos Combo Panel Type 37</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:28.424Z</lastUpdated>
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    <udiDi>D-B1016-159SK</udiDi>
    <basicUdiDi>B-B1016-159SK</basicUdiDi>
    <tradeName>MicroScan Neg Urine Combo Panel Type 59</tradeName>
    <deviceName>MicroScan Neg Urine Combo Panel Type 59</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <udiDi>D-B1016-158SH</udiDi>
    <basicUdiDi>B-B1016-158SH</basicUdiDi>
    <tradeName>MicroScan Neg Combo Panel Type 58</tradeName>
    <deviceName>MicroScan Neg Combo Panel Type 58</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <udiDi>D-B1016-152S5</udiDi>
    <basicUdiDi>B-B1016-152S5</basicUdiDi>
    <tradeName>MicroScan Pos Breakpoint Combo Panel Type 32</tradeName>
    <deviceName>MicroScan Pos Breakpoint Combo Panel Type 32</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-152</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:23.613Z</lastUpdated>
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    <udiDi>D-B1016-156SD</udiDi>
    <basicUdiDi>B-B1016-156SD</basicUdiDi>
    <tradeName>MicroScan Neg Urine Combo Panel Type 57</tradeName>
    <deviceName>MicroScan Neg Urine Combo Panel Type 57</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>B1016-156</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:22.007Z</lastUpdated>
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    <udiDi>D-B1016-155SB</udiDi>
    <basicUdiDi>B-B1016-155SB</basicUdiDi>
    <tradeName>MicroScan Neg MIC Panel Type 39</tradeName>
    <deviceName>MicroScan Neg MIC Panel Type 39</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>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-155</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:21.314Z</lastUpdated>
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    <udiDi>D-B1016-143S4</udiDi>
    <basicUdiDi>B-B1016-143S4</basicUdiDi>
    <tradeName>MicroScan Neg Combo Panel Type 54</tradeName>
    <deviceName>MicroScan Neg Combo Panel Type 54</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-143</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:05.158Z</lastUpdated>
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  <row>
    <udiDi>D-B1016-142S2</udiDi>
    <basicUdiDi>B-B1016-142S2</basicUdiDi>
    <tradeName>MicroScan Neg Combo Panel Type 53</tradeName>
    <deviceName>MicroScan Neg Combo Panel Type 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>B1016-142</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:04.360Z</lastUpdated>
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  <row>
    <udiDi>D-B1016-141RY</udiDi>
    <basicUdiDi>B-B1016-141RY</basicUdiDi>
    <tradeName>MicroScan Neg Urine Combo Panel Type 52</tradeName>
    <deviceName>MicroScan Neg Urine Combo Panel Type 52</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>B1016-141</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:03.560Z</lastUpdated>
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  <row>
    <udiDi>D-B1016-140RW</udiDi>
    <basicUdiDi>B-B1016-140RW</basicUdiDi>
    <tradeName>MicroScan Pos Combo Panel Type 32</tradeName>
    <deviceName>MicroScan Pos Combo Panel Type 32</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>B1016-140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:48:02.855Z</lastUpdated>
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  <row>
    <udiDi>D-B1016-138SB</udiDi>
    <basicUdiDi>B-B1016-138SB</basicUdiDi>
    <tradeName>MicroScan Pos Breakpoint Combo Panel Type 28</tradeName>
    <deviceName>MicroScan Pos Breakpoint Combo Panel Type 28</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>B1016-138</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:47:57.963Z</lastUpdated>
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    <udiDi>D-B1016-137S9</udiDi>
    <basicUdiDi>B-B1016-137S9</basicUdiDi>
    <tradeName>MicroScan Neg Breakpoint Combo Panel Type 42</tradeName>
    <deviceName>MicroScan Neg Breakpoint Combo Panel Type 42</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>B1016-137</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:47:57.169Z</lastUpdated>
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  <row>
    <udiDi>D-B1012-10BR8</udiDi>
    <basicUdiDi>B-B1012-10BR8</basicUdiDi>
    <tradeName>MicroScan HNID Panel Type</tradeName>
    <deviceName>MicroScan HNID Panel Type</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>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1012-10B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:47:50.774Z</lastUpdated>
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    <udiDi>08809892190026</udiDi>
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    <tradeName>IDSys Elite</tradeName>
    <deviceName>IDSys Elite</deviceName>
    <manufacturerName>ASTA Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000051737</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMS-EB-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:03:14.041Z</lastUpdated>
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    <udiDi>08800044300034</udiDi>
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    <tradeName>dRAST</tradeName>
    <deviceName>dRAST</deviceName>
    <manufacturerName>QuantaMatrix Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022784</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QMdRASTR02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:34.031Z</lastUpdated>
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    <tradeName>Radian Expert System</tradeName>
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    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-RADIAN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:40.333Z</lastUpdated>
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    <tradeName>SOFTWARE HALO MEASURE &amp; VISUAL</tradeName>
    <deviceName>SOFTWARE HALO MEASURE &amp; VISUAL</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-SW-HALO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:39.541Z</lastUpdated>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:33.929Z</lastUpdated>
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    <tradeName>Colibrì PRIMARY TUBE FOR VITEK 2</tradeName>
    <deviceName>Primary Tubes</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
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    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR090-01-0002</reference>
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    <lastUpdated>2026-07-03T05:35:18.655Z</lastUpdated>
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    <tradeName>PBS solution 2ml</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR086-03-1015</reference>
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