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<eudamedExport entity="devices">
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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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  <row>
    <udiDi>05060536830750</udiDi>
    <basicUdiDi>506053683BBOT01ZU</basicUdiDi>
    <tradeName>Benchbot® 4800</tradeName>
    <deviceName>BENCHbot 4800</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BBOT4800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:48:01.245Z</lastUpdated>
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  <row>
    <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>
    <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>65400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:46:58.729Z</lastUpdated>
  </row>
  <row>
    <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>
    <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>62010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:46:57.120Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <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-DS200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:54.688Z</lastUpdated>
  </row>
  <row>
    <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>
    <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-10DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:43.479Z</lastUpdated>
  </row>
  <row>
    <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>
    <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-10DA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:42.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025832</udiDi>
    <basicUdiDi>505601300CEIFEDIL3S</basicUdiDi>
    <tradeName>UltraCE IFE Diluent</tradeName>
    <deviceName>UltraCE IFE Diluent</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8150</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:32.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025818</udiDi>
    <basicUdiDi>505601300ULTCEURPREPXK</basicUdiDi>
    <tradeName>UltraCE Urine Prep</tradeName>
    <deviceName>UltraCE Urine Prep</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:27.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025764</udiDi>
    <basicUdiDi>505601300ULTCEBUFS5Z</basicUdiDi>
    <tradeName>UltraCE Maintenance Buffer</tradeName>
    <deviceName>CE Maintenance and Storage Buffers</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:09.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025757</udiDi>
    <basicUdiDi>505601300V8ULTRACE3Z</basicUdiDi>
    <tradeName>V8 UltraCE</tradeName>
    <deviceName>V8 UltraCE</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V801</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:08.466Z</lastUpdated>
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    <udiDi>05055331305121</udiDi>
    <basicUdiDi>50553313OP309700005N5</basicUdiDi>
    <tradeName>Bond Open Container 30 mL</tradeName>
    <deviceName>BOND Open Containers (30mL)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079085</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP309700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:15:04.283Z</lastUpdated>
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    <udiDi>05055331305114</udiDi>
    <basicUdiDi>50553313OP791900005SW</basicUdiDi>
    <tradeName>Bond Open Container 7 mL</tradeName>
    <deviceName>BOND Open Containers (7mL)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079085</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP79193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:15:03.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331305107</udiDi>
    <basicUdiDi>50553313OPT90400005CK</basicUdiDi>
    <tradeName>BOND Titration Container 6 mL</tradeName>
    <deviceName>BOND Titration Kit</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079085</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT9049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:14:59.487Z</lastUpdated>
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