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    <manufacturerName>Bee Robotics</manufacturerName>
    <manufacturerSrn>GB-MF-000023998</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB20-H</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:58:11.555Z</lastUpdated>
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    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
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    <udiDi>05060969430022</udiDi>
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    <manufacturerName>Bee Robotics</manufacturerName>
    <manufacturerSrn>GB-MF-000023998</manufacturerSrn>
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    <deviceName>RoboBlot</deviceName>
    <manufacturerName>Bee Robotics</manufacturerName>
    <manufacturerSrn>GB-MF-000023998</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:58:09.157Z</lastUpdated>
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    <udiDi>05060599402017</udiDi>
    <basicUdiDi>5060599401038XK</basicUdiDi>
    <tradeName>Automatic Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RL-CLIA-1A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:48:07.628Z</lastUpdated>
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    <udiDi>05060456180058</udiDi>
    <basicUdiDi>506045618AGILITYBB</basicUdiDi>
    <tradeName>AGILITY</tradeName>
    <deviceName>AGILITY</deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:46:59.521Z</lastUpdated>
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    <udiDi>05060456180010</udiDi>
    <basicUdiDi>506045618DSXFQ</basicUdiDi>
    <tradeName>DSX Automated ELISA System with 4 incubators</tradeName>
    <deviceName>DSX Automated ELISA System</deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:46:58.729Z</lastUpdated>
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    <udiDi>05060456180003</udiDi>
    <basicUdiDi>506045618DS2DE</basicUdiDi>
    <tradeName>DS2 Automated ELISA System with Barcode scanner</tradeName>
    <deviceName>DS2 Automated ELISA System</deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:46:57.120Z</lastUpdated>
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    <udiDi>05060169696693</udiDi>
    <basicUdiDi>5060169696693Z4</basicUdiDi>
    <tradeName>IDS i20</tradeName>
    <deviceName>IDS i20</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-910400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:09.902Z</lastUpdated>
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    <udiDi>05060169696594</udiDi>
    <basicUdiDi>5060169699625Z8</basicUdiDi>
    <tradeName>i-Tracker10</tradeName>
    <deviceName>IDS-i10T</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD 810400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:09.099Z</lastUpdated>
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    <udiDi>05060169693968</udiDi>
    <basicUdiDi>5060169693968YX</basicUdiDi>
    <tradeName>IDS-i10</tradeName>
    <deviceName>IDS-i10</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-810400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:57.086Z</lastUpdated>
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    <udiDi>05060169693906</udiDi>
    <basicUdiDi>5060169693906Y9</basicUdiDi>
    <tradeName>IDS Immunocleaner</tradeName>
    <deviceName>IDS Immunocleaner</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-IM100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:56.280Z</lastUpdated>
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    <udiDi>05060169693418</udiDi>
    <basicUdiDi>5060169693418XP</basicUdiDi>
    <tradeName>IDS-iSYS Diluent C</tradeName>
    <deviceName>IDS-iSYS Diluent C</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-10DC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:55.485Z</lastUpdated>
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    <udiDi>05060169692305</udiDi>
    <basicUdiDi>5060169692305X2</basicUdiDi>
    <tradeName>IDS-iSYS D-Sorb Solution</tradeName>
    <deviceName>IDS-iSYS D-Sorb Solution</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-DS200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:54.688Z</lastUpdated>
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    <udiDi>05060169691100</udiDi>
    <basicUdiDi>5060169691100W7</basicUdiDi>
    <tradeName>IDS-iSYS Diluent B</tradeName>
    <deviceName>IDS-iSYS Diluent B</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-10DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:43.479Z</lastUpdated>
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    <udiDi>05060169691094</udiDi>
    <basicUdiDi>5060169691094X5</basicUdiDi>
    <tradeName>IDS-iSYS Diluent A</tradeName>
    <deviceName>IS-10DA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-10DA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:42.686Z</lastUpdated>
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    <tradeName>EVIDENCE+</tradeName>
    <deviceName>EVIDENCE+</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4400</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:53.773Z</lastUpdated>
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    <tradeName>evidence MULTISTAT</tradeName>
    <deviceName>evidence MULTISTAT</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4115</reference>
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    <lastUpdated>2026-07-31T05:12:33.766Z</lastUpdated>
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    <tradeName>WASH BUFFER CONCENTRATE (BUF WASH (conc.))</tradeName>
    <deviceName>WASH BUFFER CONCENTRATE (BUF WASH (conc.))</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3581</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:15.330Z</lastUpdated>
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    <tradeName>DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.))</tradeName>
    <deviceName>DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.))</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3580</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:13.665Z</lastUpdated>
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