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    <udiDi>05055273219036</udiDi>
    <basicUdiDi>50552732BAVB12C173QK</basicUdiDi>
    <tradeName>ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2)</tradeName>
    <deviceName>ACTIVE VITAMIN B12 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VB10525</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:46:50.060Z</lastUpdated>
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    <udiDi>05055273220001</udiDi>
    <basicUdiDi>50552732CTXPLXU068B8</basicUdiDi>
    <tradeName>Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array</tradeName>
    <deviceName>Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4505</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:41.828Z</lastUpdated>
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    <udiDi>05055273219586</udiDi>
    <basicUdiDi>50552732BTESCON162Q2</basicUdiDi>
    <tradeName>Evidence MultiSTAT Testosterone Control</tradeName>
    <deviceName>Evidence MultiSTAT Testosterone 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>EV4532</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:41.024Z</lastUpdated>
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    <udiDi>05055273219555</udiDi>
    <basicUdiDi>50552732BTESASS161RM</basicUdiDi>
    <tradeName>Evidence MultiSTAT Testosterone</tradeName>
    <deviceName>Evidence MultiSTAT Testosterone</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>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4513</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:40.221Z</lastUpdated>
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    <udiDi>05055273219098</udiDi>
    <basicUdiDi>50552732BSUBOMK154TC</basicUdiDi>
    <tradeName>SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1)</tradeName>
    <deviceName>SERUM BONE MARKER 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>SBM10574</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:39.454Z</lastUpdated>
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    <udiDi>05055273218992</udiDi>
    <basicUdiDi>50552732CPREECL063JH</basicUdiDi>
    <tradeName>PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)</tradeName>
    <deviceName>PRE-ECLAMPSIA CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE10529</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:38.648Z</lastUpdated>
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    <udiDi>05055273218985</udiDi>
    <basicUdiDi>50552732CCELISA0649X</basicUdiDi>
    <tradeName>ConcizuTrace™ ELISA</tradeName>
    <deviceName>ConcizuTrace™ ELISA</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CZM10591</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:37.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215601</udiDi>
    <basicUdiDi>50552732BSTFCON103QT</basicUdiDi>
    <tradeName>SOLUBLE TRANSFERRIN RECEPTORS CONTROLS (STFR CONTROL)</tradeName>
    <deviceName>SOLUBLE TRANSFERRIN RECEPTORS 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF10162</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:37.053Z</lastUpdated>
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    <udiDi>05055273218787</udiDi>
    <basicUdiDi>50552732CULOPSA062XC</basicUdiDi>
    <tradeName>Ultra-Low PSA Control (UL PSA Control)</tradeName>
    <deviceName>Ultra-Low PSA Control (UL PSA Control)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU10523</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:36.235Z</lastUpdated>
  </row>
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    <udiDi>05055273218725</udiDi>
    <basicUdiDi>50552732BXTHPON1553F</basicUdiDi>
    <tradeName>XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)</tradeName>
    <deviceName>XANTHOCHROMIA 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>XN10505</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:35.423Z</lastUpdated>
  </row>
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    <udiDi>05055273218480</udiDi>
    <basicUdiDi>50552732CBNPCON061FJ</basicUdiDi>
    <tradeName>BNP CONTROLS FOR BECKMAN (BNP CONTROL)</tradeName>
    <deviceName>BNP CONTROLS</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>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ10520</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:34.637Z</lastUpdated>
  </row>
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    <udiDi>05055273204728</udiDi>
    <basicUdiDi>50552732BTTATSS111Y8</basicUdiDi>
    <tradeName>TOTAL ANTIOXIDANT STATUS (TAS CONTROL)</tradeName>
    <deviceName>TOTAL ANTIOXIDANT STATUS 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX2331</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:33.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273215557</udiDi>
    <basicUdiDi>50552732BSTFCAL104KM</basicUdiDi>
    <tradeName>SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL)</tradeName>
    <deviceName>SOLUBLE TRANSFERRIN RECEPTORS 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>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF10161</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:32.219Z</lastUpdated>
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    <udiDi>05055273215052</udiDi>
    <basicUdiDi>50552732BURLOCA066SR</basicUdiDi>
    <tradeName>URINE LOW/HIGH CALIBRATORS (ISE CAL U)</tradeName>
    <deviceName>URINE LOW/HIGH CALIBRATORS</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>REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS2910</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:31.422Z</lastUpdated>
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    <udiDi>05055273215038</udiDi>
    <basicUdiDi>50552732BSLHCAL174GL</basicUdiDi>
    <tradeName>SERUM LOW/HIGH CALIBRATORS (ISE CAL S)</tradeName>
    <deviceName>SERUM LOW/HIGH CALIBRATORS</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>REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS2909</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:30.620Z</lastUpdated>
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    <udiDi>05055273220377</udiDi>
    <basicUdiDi>50552732BLOOSMC160RD</basicUdiDi>
    <tradeName>URINE LOW OSMOLALITY CONTROL</tradeName>
    <deviceName>URINE LOW OSMOLALITY 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>UC10650</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:36.449Z</lastUpdated>
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    <udiDi>05055273220292</udiDi>
    <basicUdiDi>50552732ACBSCKD0615C</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit D</tradeName>
    <deviceName>Capillary Blood Sample Collection Kit D</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>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10719</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:35.634Z</lastUpdated>
  </row>
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    <udiDi>05055273220179</udiDi>
    <basicUdiDi>50552732ACBSCKC06053</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit C</tradeName>
    <deviceName>VENOUS BLOOD SAMPLE COLLECTION KIT</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>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10674</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:34.834Z</lastUpdated>
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    <udiDi>05055273220155</udiDi>
    <basicUdiDi>50552732ACBSCKA05852</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit A</tradeName>
    <deviceName>Capillary Blood Sample Collection Kit A</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>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10672</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:34.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220148</udiDi>
    <basicUdiDi>50552732ACBSCKB0595B</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit B</tradeName>
    <deviceName>Capillary Blood Sample Collection Kit B</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>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10673</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:33.228Z</lastUpdated>
  </row>
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