<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055273217025</udiDi>
    <basicUdiDi>50552732BSEMDCE128EF</basicUdiDi>
    <tradeName>SERUM INDICES (SERUM INDICES)</tradeName>
    <deviceName>SERUM INDICES</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI10448</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:01.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216981</udiDi>
    <basicUdiDi>50552732BLTTCON151TK</basicUdiDi>
    <tradeName>TROPONIN T CONTROL (TROPONIN T CONTROL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ10462</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:01.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216943</udiDi>
    <basicUdiDi>50552732ADISCOV018FH</basicUdiDi>
    <tradeName>Randox Discovery</tradeName>
    <deviceName>Randox Discovery</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MICRO-ARRAY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDC10000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:00.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216691</udiDi>
    <basicUdiDi>50552732AEVIDEN019DW</basicUdiDi>
    <tradeName>EVIDENCE+</tradeName>
    <deviceName>EVIDENCE+</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4400</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:59.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216615</udiDi>
    <basicUdiDi>50552732BLSPC1218199</basicUdiDi>
    <tradeName>CUSTOM LIQUID SPECIFIC PROTEIN CONTROL - LEVEL 1</tradeName>
    <deviceName>CUSTOM LIQUID SPECIFIC PROTEIN CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3151</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:57.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216493</udiDi>
    <basicUdiDi>50552732BSECONT122LA</basicUdiDi>
    <tradeName>SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL NEGATIVE)</tradeName>
    <deviceName>SEROLOGY CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10351</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:57.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216400</udiDi>
    <basicUdiDi>50552732BSETECO123LF</basicUdiDi>
    <tradeName>SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)</tradeName>
    <deviceName>SEROLOGY ToRCH CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10347</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:56.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273216387</udiDi>
    <basicUdiDi>50552732BSELYDC124N4</basicUdiDi>
    <tradeName>SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)</tradeName>
    <deviceName>SEROLOGY LYME DISEASE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10345</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:55.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215328</udiDi>
    <basicUdiDi>50552732BPHCLLC090EN</basicUdiDi>
    <tradeName>PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)</tradeName>
    <deviceName>PARATHYROID HORMONE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTH10110</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:54.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215045</udiDi>
    <basicUdiDi>50552732AISEDET032DX</basicUdiDi>
    <tradeName>ISE DETERGENT (ISE DET)</tradeName>
    <deviceName>ISE DETERGENT (ISE DET)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX8128</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:53.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215021</udiDi>
    <basicUdiDi>50552732AAWSOLN028PU</basicUdiDi>
    <tradeName>ACID WASH SOLUTION (WASH SOLN. 3)</tradeName>
    <deviceName>ACID WASH SOLUTION (WASH SOLN. 3)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX8129</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:53.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215014</udiDi>
    <basicUdiDi>50552732AISEBUF031FH</basicUdiDi>
    <tradeName>ISE BUFFER (ISE BUF)</tradeName>
    <deviceName>ISE BUFFER (ISE BUF)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX8126</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:52.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215007</udiDi>
    <basicUdiDi>50552732AALSOLN029HD</basicUdiDi>
    <tradeName>ALKALINE WASH SOLUTION (WASH soln. 9)</tradeName>
    <deviceName>ALKALINE WASH SOLUTION (WASH soln. 9)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX8130</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:51.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214970</udiDi>
    <basicUdiDi>50552732AEVMULT038SS</basicUdiDi>
    <tradeName>evidence MULTISTAT</tradeName>
    <deviceName>evidence MULTISTAT</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4115</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:50.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214963</udiDi>
    <basicUdiDi>50552732AMODENA033DB</basicUdiDi>
    <tradeName>RX modena</tradeName>
    <deviceName>RX modena</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX9000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:49.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214802</udiDi>
    <basicUdiDi>50552732BLUCN121507N</basicUdiDi>
    <tradeName>CUSTOM LIQUID URINE CONTROL - LEVEL 1</tradeName>
    <deviceName>CUSTOM LIQUID URINE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC5170</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:49.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214529</udiDi>
    <basicUdiDi>50552732AAWSOLN016PM</basicUdiDi>
    <tradeName>ACID WASH SOLUTION (AWS)</tradeName>
    <deviceName>ACID WASH SOLUTION (AWS)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WS8397</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:48.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214376</udiDi>
    <basicUdiDi>50552732AISEDIL011DB</basicUdiDi>
    <tradeName>I.S.E. DILUENT (ISE DIL)</tradeName>
    <deviceName>I.S.E. DILUENT (ISE DIL)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX4049</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:47.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214369</udiDi>
    <basicUdiDi>50552732ARXETCH012SD</basicUdiDi>
    <tradeName>ETCHING (ETCH)</tradeName>
    <deviceName>ETCHING (ETCH)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX4048</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:46.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214352</udiDi>
    <basicUdiDi>50552732AISECLN044EU</basicUdiDi>
    <tradeName>I.S.E. CLEANER (ISE CLN)</tradeName>
    <deviceName>I.S.E. CLEANER (ISE CLN)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX4047</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:45.936Z</lastUpdated>
  </row>
</eudamedExport>