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    <udiDi>05055273206111</udiDi>
    <basicUdiDi>50552732ASALDIL007DT</basicUdiDi>
    <tradeName>NORMAL SALINE (NS)</tradeName>
    <deviceName>SALINE DILUENT</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>SA3854</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:29.126Z</lastUpdated>
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  <row>
    <udiDi>05055273206104</udiDi>
    <basicUdiDi>50552732ARXIMOL025WX</basicUdiDi>
    <tradeName>RX imola</tradeName>
    <deviceName>RX imola</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>RX4900</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:28.436Z</lastUpdated>
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  <row>
    <udiDi>05055273205947</udiDi>
    <basicUdiDi>50552732AWASCON008NK</basicUdiDi>
    <tradeName>RX WASH CONCENTRATE (WASH conc. 3)</tradeName>
    <deviceName>RX WASH CONCENTRATE (WASH conc.)</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>RX3946</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:14.688Z</lastUpdated>
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    <udiDi>05055273204667</udiDi>
    <basicUdiDi>50552732ASERDIL048KT</basicUdiDi>
    <tradeName>SERUM DILUENT (DIL SM)</tradeName>
    <deviceName>SERUM DILUENT (DIL SM)</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>MS5007</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:13.892Z</lastUpdated>
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  <row>
    <udiDi>05055273204520</udiDi>
    <basicUdiDi>50552732BMALBCL08688</basicUdiDi>
    <tradeName>MICROALBUMIN CALIBRATOR SERIES (mALB CAL)</tradeName>
    <deviceName>MICROALBUMIN CALIBRATOR SERIES</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>MA1567</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:13.087Z</lastUpdated>
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    <udiDi>05055273204445</udiDi>
    <basicUdiDi>50552732BLIPCON082K4</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)</tradeName>
    <deviceName>LIPOPROTEIN (a) 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>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP3406</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:12.269Z</lastUpdated>
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    <udiDi>05055273204438</udiDi>
    <basicUdiDi>50552732BLCALSS081DM</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET)</tradeName>
    <deviceName>LIPOPROTEIN (a) CALIBRATOR SERIES</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>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP3404</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:11.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273204414</udiDi>
    <basicUdiDi>50552732BAPOCAL01594</basicUdiDi>
    <tradeName>APOLIPOPROTEIN CALIBRATOR (APO CAL)</tradeName>
    <deviceName>APOLIPOPROTEIN CALIBRATOR</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 STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP3023</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:10.684Z</lastUpdated>
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  <row>
    <udiDi>05055273204155</udiDi>
    <basicUdiDi>50552732BLPDCON080GR</basicUdiDi>
    <tradeName>LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)</tradeName>
    <deviceName>LIPID 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>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE2661</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:09.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273204056</udiDi>
    <basicUdiDi>50552732BILPCAL107D7</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL)</tradeName>
    <deviceName>IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG 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>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT3861</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:09.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273204049</udiDi>
    <basicUdiDi>50552732BLUPCAL106LM</basicUdiDi>
    <tradeName>LIQUID PROTEIN CALIBRATORS (SP CAL (LIQ))</tradeName>
    <deviceName>LIQUID PROTEIN CALIBRATORS (SP CAL (LIQ))</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 STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT2692</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:08.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273202663</udiDi>
    <basicUdiDi>50552732ABUFWAS021GL</basicUdiDi>
    <tradeName>WASH BUFFER CONCENTRATE (BUF WASH (conc.))</tradeName>
    <deviceName>WASH BUFFER CONCENTRATE (BUF WASH (conc.))</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 - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3581</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:07.488Z</lastUpdated>
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  <row>
    <udiDi>05055273202656</udiDi>
    <basicUdiDi>50552732ADISFLU049FT</basicUdiDi>
    <tradeName>DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.))</tradeName>
    <deviceName>DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.))</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 - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3580</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:06.725Z</lastUpdated>
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  <row>
    <udiDi>05055273202335</udiDi>
    <basicUdiDi>50552732AREASGN020F8</basicUdiDi>
    <tradeName>SIGNAL REAGENTS – EV805 (REAG SGNL – EV805)</tradeName>
    <deviceName>SIGNAL REAGENTS (REAG SGNL)</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 - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3529</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:05.893Z</lastUpdated>
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    <udiDi>05055273202090</udiDi>
    <basicUdiDi>50552732BAMMCON049C2</basicUdiDi>
    <tradeName>AMMONIA ETHANOL CONTROL - LEVEL 1 (NH3/EtOH CONTROL 1)</tradeName>
    <deviceName>AMMONIA ETHANOL 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>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA1366</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:05.099Z</lastUpdated>
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    <udiDi>05055273201239</udiDi>
    <basicUdiDi>50552732BDIHDCA02628</basicUdiDi>
    <tradeName>DIRECT LDL/HDL CHOLESTEROL CALIBRATOR</tradeName>
    <deviceName>DIRECT LDL/HDL CHOLESTEROL CALIBRATOR</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 MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH2673</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:04.273Z</lastUpdated>
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    <udiDi>05055273201116</udiDi>
    <basicUdiDi>50552732BCSFCON038D6</basicUdiDi>
    <tradeName>CSF CONTROL - LEVEL 2  (CSF CONTROL 2)</tradeName>
    <deviceName>CSF 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>CSF CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF1500</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:02.694Z</lastUpdated>
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    <udiDi>05055273200096</udiDi>
    <basicUdiDi>50552732BALSCON005DZ</basicUdiDi>
    <tradeName>ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2)</tradeName>
    <deviceName>ALDOLASE 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>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD5001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:01.869Z</lastUpdated>
  </row>
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    <udiDi>05055273200089</udiDi>
    <basicUdiDi>50552732BALSCAL0048P</basicUdiDi>
    <tradeName>ALDOLASE CALIBRATION SERUM (ALS CAL)</tradeName>
    <deviceName>ALDOLASE CALIBRATION SERUM</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>AD5000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:41:01.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273200102</udiDi>
    <basicUdiDi>50552732BALSCON005DZ</basicUdiDi>
    <tradeName>ALDOLASE LEVEL 3 CONTROL (ALS CONTROL 3)</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></emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD5002</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:28.043Z</lastUpdated>
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