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<eudamedExport entity="devices">
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    <basicUdiDi>506045618DSXFQ</basicUdiDi>
    <tradeName>DSX Automated ELISA System - Ambient</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:52.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180218</udiDi>
    <basicUdiDi>506045618DSXFQ</basicUdiDi>
    <tradeName>DSX Automated ELISA with 2 incubators and sample ID</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:51.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180157</udiDi>
    <basicUdiDi>506045618DSXFQ</basicUdiDi>
    <tradeName>DSX Automated ELISA System with 2 incubators</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:50.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180089</udiDi>
    <basicUdiDi>506045618AGILITYBB</basicUdiDi>
    <tradeName>AGILITY REAGENT TIPS</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6792-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:49.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180072</udiDi>
    <basicUdiDi>506045618AGILITYBB</basicUdiDi>
    <tradeName>AGILITY SAMPLE TIPS</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67910</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:48.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180041</udiDi>
    <basicUdiDi>506045618DS2DE</basicUdiDi>
    <tradeName>DS2 / DSX SAMPLE TIP</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65910</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:46.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180034</udiDi>
    <basicUdiDi>506045618DS2DE</basicUdiDi>
    <tradeName>DS2 / DSX REAGENT TIPS</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65920</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:13:45.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>50610078000366</udiDi>
    <basicUdiDi>B-50610078000366</basicUdiDi>
    <tradeName>50610078000366</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Congenica Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026168</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:18:22.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR221897</udiDi>
    <basicUdiDi>B-SZR221897</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2218</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR22238Y</udiDi>
    <basicUdiDi>B-SZR22238Y</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR22289A</udiDi>
    <basicUdiDi>B-SZR22289A</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR22328Z</udiDi>
    <basicUdiDi>B-SZR22328Z</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR22389D</udiDi>
    <basicUdiDi>B-SZR22389D</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2238</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR224396</udiDi>
    <basicUdiDi>B-SZR224396</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2243</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR22469C</udiDi>
    <basicUdiDi>B-SZR22469C</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2246</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR22489G</udiDi>
    <basicUdiDi>B-SZR22489G</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR25189N</udiDi>
    <basicUdiDi>B-SZR25189N</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR251XBL</udiDi>
    <basicUdiDi>B-SZR251XBL</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR25239F</udiDi>
    <basicUdiDi>B-SZR25239F</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2523</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR25289R</udiDi>
    <basicUdiDi>B-SZR25289R</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.358Z</lastUpdated>
  </row>
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