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<eudamedExport entity="devices">
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    <basicUdiDi>50552732AREFSOL014LC</basicUdiDi>
    <tradeName>REFERENCE SOLUTION (REF SOLN)</tradeName>
    <deviceName>REFERENCE SOLUTION (REF SOLN)</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>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX4045</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:45.137Z</lastUpdated>
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    <udiDi>05055273210385</udiDi>
    <basicUdiDi>50552732AALKDET0357E</basicUdiDi>
    <tradeName>ALKALINE DETERGENT (Alkaline Detergent)</tradeName>
    <deviceName>ALKALINE DETERGENT (Alkaline Detergent)</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>RX8108</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:44.339Z</lastUpdated>
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    <udiDi>05055273210378</udiDi>
    <basicUdiDi>50552732AANBDET0363V</basicUdiDi>
    <tradeName>ANTI-BACTERIAL DETERGENT (Detergent)</tradeName>
    <deviceName>ANTI-BACTERIAL DETERGENT (Detergent)</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>RX8106</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:43.543Z</lastUpdated>
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    <udiDi>05055273210361</udiDi>
    <basicUdiDi>50552732AISESOL006MP</basicUdiDi>
    <tradeName>I.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH)</tradeName>
    <deviceName>I.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH)</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>RX4003</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:42.739Z</lastUpdated>
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    <udiDi>05055273210200</udiDi>
    <basicUdiDi>50552732BHAECON0595S</basicUdiDi>
    <tradeName>HAEMATOLOGY CONTROL - LEVEL 1,2,3 (HAEM CNTL - LEVEL 1,2,3)</tradeName>
    <deviceName>HAEMATOLOGY CONTROL - LEVEL 1,2,3</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>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HM5162</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:41.939Z</lastUpdated>
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    <udiDi>05055273210101</udiDi>
    <basicUdiDi>50552732BLIACON169BJ</basicUdiDi>
    <tradeName>Liquid Immunoassay Control - Level 1 (IA CONTROL 1)</tradeName>
    <deviceName>Liquid Immunoassay 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>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIA5142</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:41.145Z</lastUpdated>
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    <udiDi>05055273209952</udiDi>
    <basicUdiDi>50552732AEVINVE026MR</basicUdiDi>
    <tradeName>evidence INVESTIGATOR</tradeName>
    <deviceName>evidence INVESTIGATOR</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>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3602</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:40.336Z</lastUpdated>
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    <udiDi>05055273209105</udiDi>
    <basicUdiDi>50552732BAPOCON016EE</basicUdiDi>
    <tradeName>APOLIPOPROTEIN CONTROL - LEVEL 1  (APO CONTROL 1)</tradeName>
    <deviceName>APOLIPOPROTEIN 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>LE5016</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:39.546Z</lastUpdated>
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  <row>
    <udiDi>05055273209075</udiDi>
    <basicUdiDi>50552732BSLDLCL099K6</basicUdiDi>
    <tradeName>sLDL CONTROL LEVEL 1 (sLDL CONTROL 1)</tradeName>
    <deviceName>sLDL 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 CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE5013</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:38.739Z</lastUpdated>
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  <row>
    <udiDi>05055273208436</udiDi>
    <basicUdiDi>50552732BSLDLCR100K8</basicUdiDi>
    <tradeName>sLDL CALIBRATOR (sLDL CAL)</tradeName>
    <deviceName>sLDL CALIBRATOR (sLDL CAL)</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>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH5050</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:37.932Z</lastUpdated>
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    <udiDi>05055273207873</udiDi>
    <basicUdiDi>50552732BETHCON051FZ</basicUdiDi>
    <tradeName>ETHANOL CALIBRATOR AND CONTROL SET (EtOH CAL/ CONTROL)</tradeName>
    <deviceName>ETHANOL CALIBRATOR AND CONTROL SET</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>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA2703</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:37.145Z</lastUpdated>
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    <udiDi>05055273207774</udiDi>
    <basicUdiDi>50552732ADAYPLU015HS</basicUdiDi>
    <tradeName>RX daytona plus (with ISE)</tradeName>
    <deviceName>RX daytona plus</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 - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX4040</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:36.331Z</lastUpdated>
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    <udiDi>05055273207750</udiDi>
    <basicUdiDi>50552732AMONACO037GJ</basicUdiDi>
    <tradeName>RX monaco</tradeName>
    <deviceName>RX monaco</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 - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX5000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:35.539Z</lastUpdated>
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    <udiDi>05055273207132</udiDi>
    <basicUdiDi>50552732BCUQCON121KT</basicUdiDi>
    <tradeName>LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1)</tradeName>
    <deviceName>LIQUID CHEMISTRY PREMIUM PLUS</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>LUL5069</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:34.742Z</lastUpdated>
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    <udiDi>05055273207002</udiDi>
    <basicUdiDi>50552732AZNDPSN050X4</basicUdiDi>
    <tradeName>ZINC DEPROTEINIZING SOLUTION (Zn)</tradeName>
    <deviceName>ZINC DEPROTEINIZING SOLUTION (Zn)</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZN2607</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:33.928Z</lastUpdated>
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    <udiDi>05055273206982</udiDi>
    <basicUdiDi>50552732AAWSOLN001P8</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>WS3853</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:33.138Z</lastUpdated>
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    <udiDi>05055273206791</udiDi>
    <basicUdiDi>50552732BHUPNCN127PL</basicUdiDi>
    <tradeName>HUMAN PRECISION CONTROL - LEVEL 3 (HUM PREC CONTROL 3)</tradeName>
    <deviceName>HUMAN PRECISION 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>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UE1558</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:32.353Z</lastUpdated>
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    <udiDi>05055273206142</udiDi>
    <basicUdiDi>50552732ARANDIL045EE</basicUdiDi>
    <tradeName>RANSOD DILUENT (RANSOD DIL)</tradeName>
    <deviceName>RANSOD DILUENT (RANSOD 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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD124</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:31.527Z</lastUpdated>
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    <udiDi>05055273206074</udiDi>
    <basicUdiDi>50552732AC1SOLN00937</basicUdiDi>
    <tradeName>C1 Solution (C1 SOLN)</tradeName>
    <deviceName>C1 SOLUTION (C1 SOLN)</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>RX3973</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:30.730Z</lastUpdated>
  </row>
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    <udiDi>05055273205961</udiDi>
    <basicUdiDi>50552732AISEDIL005DG</basicUdiDi>
    <tradeName>I.S.E. URINE DILUENT (ISE DIL URN)</tradeName>
    <deviceName>I.S.E. URINE DILUENT (ISE DIL URN)</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX3950</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:29.928Z</lastUpdated>
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